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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65876

86 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 26, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Beacon Hill Medical Pharmacy, P.C.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

86 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 86

SODIUM PHOSPHATE DIBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1000-2013
Recall number
D-1000-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01242013@11

Distribution pattern

USA nationwide

drug · product 2 of 86

SODIUM PHOSPHATE MONOBASIC/WATER FOR INJECTION 10%, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1001-2013
Recall number
D-1001-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01242013@5

Distribution pattern

USA nationwide

drug · product 3 of 86

TESTOSTERONE HYPOALLERGENIC 200 MG/ML INJECTABLE and TESTOSTERONE AQUEOUS 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1002-2013
Recall number
D-1002-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03112013@9, 05242013@17, 05312013@7, 06052013@21

Distribution pattern

USA nationwide

drug · product 4 of 86

TESTOSTERONE CYPIONATE 100 MG/ML, 200 MG/ML, 20 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1003-2013
Recall number
D-1003-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07222013@15, 04192013@5, 06272013@26, 07012013@5

Distribution pattern

USA nationwide

drug · product 5 of 86

TESTOSTERONE PROPIONATE 100 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1004-2013
Recall number
D-1004-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04172013@15, 06042013@17

Distribution pattern

USA nationwide

drug · product 6 of 86

TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1005-2013
Recall number
D-1005-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04302013@22, 02132013@8, 04122013@27, 06262013@28

Distribution pattern

USA nationwide

drug · product 7 of 86

TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1006-2013
Recall number
D-1006-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03252013@20, 04152013@11, 05232013@25, 06052013@32, 07022013@24

Distribution pattern

USA nationwide

drug · product 8 of 86

TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1007-2013
Recall number
D-1007-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07182013@1, 03202013@19, 01022013@31, 01292013@2, 04182013@10, 06142013@1, 07122013@1, 07132013@9

Distribution pattern

USA nationwide

drug · product 9 of 86

TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1008-2013
Recall number
D-1008-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2

Distribution pattern

USA nationwide

drug · product 10 of 86

VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1009-2013
Recall number
D-1009-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07022013@37, 01152013@32, 03012013@22, 03062013@15, 03122013@14, 04102013@4, 04242013@14, 04302013@2, 05242013@9, 06122013@26, 06122013@20, 07112013@16, 07232013@2

Distribution pattern

USA nationwide

drug · product 11 of 86

VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1010-2013
Recall number
D-1010-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03082013@20, 07032013@15

Distribution pattern

USA nationwide

drug · product 12 of 86

Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1011-2013
Recall number
D-1011-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02082013@9, 06102013@16

Distribution pattern

USA nationwide

drug · product 13 of 86

ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1012-2013
Recall number
D-1012-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06262013@33

Distribution pattern

USA nationwide

drug · product 14 of 86

ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1013-2013
Recall number
D-1013-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02202013@9 and 04052013@2

Distribution pattern

USA nationwide

drug · product 15 of 86

B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1014-2013
Recall number
D-1014-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01112013@18, 02112013@8, 03052013@11, 04032013@19, 04122013@34, 05132013@18, 06052013@37, 06212013@14 and 06292013@7

Distribution pattern

USA nationwide

drug · product 16 of 86

BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1015-2013
Recall number
D-1015-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04252013@12 and 07232013@25

Distribution pattern

USA nationwide

drug · product 17 of 86

CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1016-2013
Recall number
D-1016-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02112013@14 and 04102013@25

Distribution pattern

USA nationwide

drug · product 18 of 86

CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1017-2013
Recall number
D-1017-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01082013@7 and 05062013@29

Distribution pattern

USA nationwide

drug · product 19 of 86

MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-1018-2013
Recall number
D-1018-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01212013@8, 04042013@15 and 06272013@29

Distribution pattern

USA nationwide

drug · product 20 of 86

ACETYLCYSTEINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-933-2013
Recall number
D-933-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06252013@14

Distribution pattern

USA nationwide

drug · product 21 of 86

ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-934-2013
Recall number
D-934-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02082013@12 06072013@22 06152013@1 07252013@13

Distribution pattern

USA nationwide

drug · product 22 of 86

B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-935-2013
Recall number
D-935-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01092013@13

Distribution pattern

USA nationwide

drug · product 23 of 86

B-COMPLEX/LIDO/B-12, 25MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-936-2013
Recall number
D-936-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03202013@33

Distribution pattern

USA nationwide

drug · product 24 of 86

ALPROSTADIL, 50 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-937-2013
Recall number
D-937-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07232013@28

Distribution pattern

USA nationwide

drug · product 25 of 86

ARGININE (R-GENE) 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-938-2013
Recall number
D-938-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03262013@3, 04302013@21, 06132013@1, 07102013@22

Distribution pattern

USA nationwide

drug · product 26 of 86

B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-939-2013
Recall number
D-939-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04222013@23

Distribution pattern

USA nationwide

drug · product 27 of 86

B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-940-2013
Recall number
D-940-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance.

Code information

03202013@31

Distribution pattern

USA nationwide

drug · product 28 of 86

BI-MIX PHENTOLAMINE/PAPAVERINE 0.5 MG/30 MG/ML and BI-MIX PHENTOLAMINE/PAPAVERINE 1 MG/30 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-941-2013
Recall number
D-941-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07232013@23 and 04232013@27

Distribution pattern

USA nationwide

drug · product 29 of 86

BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-942-2013
Recall number
D-942-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01242013@2, 04172013@8, 05242013@7, 07152013@9

Distribution pattern

USA nationwide

drug · product 30 of 86

CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-943-2013
Recall number
D-943-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02042013@22, 04102013@23, 05072013@18, 05312013@23, 07242013@3

Distribution pattern

USA nationwide

drug · product 31 of 86

CHROMIUM 4 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-944-2013
Recall number
D-944-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01152013@5, 04242013@32

Distribution pattern

USA nationwide

drug · product 32 of 86

COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-945-2013
Recall number
D-945-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04042013@23

Distribution pattern

USA nationwide

drug · product 33 of 86

CYANOCOBALAMIN 1000 MCG/ML INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-946-2013
Recall number
D-946-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01092013@12, 02132013@17, 03122013@21, 04122013@33, 05132013@17 05282013@26, 06052013@33, 06252013@4, 06272013@2, 07152013@41

Distribution pattern

USA nationwide

drug · product 34 of 86

DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-947-2013
Recall number
D-947-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01162013@13, 05202013@23, 07112013@11

Distribution pattern

USA nationwide

drug · product 35 of 86

DEXPANTHENOL 250 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-948-2013
Recall number
D-948-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06262013@42

Distribution pattern

USA nationwide

drug · product 36 of 86

DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-949-2013
Recall number
D-949-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05202013@11, 07092013@19

Distribution pattern

USA nationwide

drug · product 37 of 86

DMSO 50% INJ 50 ML VIAL INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-950-2013
Recall number
D-950-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07162013@16 and 02262013@9

Distribution pattern

USA nationwide

drug · product 38 of 86

DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-951-2013
Recall number
D-951-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03152013@19, 07012013@9

Distribution pattern

USA nationwide

drug · product 39 of 86

DUAL-TESTOSTERONE 20, 50, 100, 150, 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-952-2013
Recall number
D-952-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05302013@6, 02112013@5, 04192013@21, 05032013@14, 01252013@11, 03272013@17, 01252013@8, 03272013@22, 01312013@9, 06062013@24, 01032013@1, 01152013@14, 01292013@4, 01312013@10, 02142013@9, 03062013@10, 03112013@6, 03112013@4, 04042013@16, 04122013@18, 04302013@24, 05102013@18, 05282013@29, 06042013@18, 06282013@10, 07112013@21, 07232013@1, 07282013@1, 07282013@2, 01312013@8, 05222013@26.

Distribution pattern

USA nationwide

drug · product 40 of 86

EDETATE DISODIUM 150 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-953-2013
Recall number
D-953-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07172013@4, 01222013@14, 03072013@10, 04032013@1, 05162013@17, 06042013@30m, 07092013@17, and 07262013@2

Distribution pattern

USA nationwide

drug · product 41 of 86

ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-954-2013
Recall number
D-954-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05012013@25, 06202013@6

Distribution pattern

USA nationwide

drug · product 42 of 86

ESTRADIOL CYPIONATE 5, 10, 40 MG/ML OIL INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-955-2013
Recall number
D-955-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02072013@11, 04042013@14, 01312013@3, 01072013@8

Distribution pattern

USA nationwide

drug · product 43 of 86

ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-956-2013
Recall number
D-956-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05022013@21

Distribution pattern

USA nationwide

drug · product 44 of 86

ESTRIOL 5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-957-2013
Recall number
D-957-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02042013@21, 02262013@3, 07242013@38

Distribution pattern

USA nationwide

drug · product 45 of 86

FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-958-2013
Recall number
D-958-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03262013@11, 01212013@12, 02112013@17, 02262013@7, 03012013@17, 04102013@8, 04112013@7, 04292013@20, 05212013@4, 06042013@12, 06202013@3, 07152013@19, 07242013@14,

Distribution pattern

USA nationwide

drug · product 46 of 86

FUROSEMIDE 10 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-959-2013
Recall number
D-959-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01162013@14, 02132013@18

Distribution pattern

USA nationwide

drug · product 47 of 86

GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-960-2013
Recall number
D-960-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06262013@22

Distribution pattern

USA nationwide

drug · product 48 of 86

GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-961-2013
Recall number
D-961-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03192013@30, 02202013@6, 04042013@2, 04302013@20, 04252013@19 06202013@35, 06212013@17

Distribution pattern

USA nationwide

drug · product 49 of 86

GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-962-2013
Recall number
D-962-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03202013@28, 04022013@23, 04042013@3, 06172013@25

Distribution pattern

USA nationwide

drug · product 50 of 86

GLUTATHIONE/METHYL/LIDO 100/25/20 MG/ML INJ SOLN and GLUTATHIONE/METHYL/LIDO 100/25/20MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-963-2013
Recall number
D-963-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06132013@6 04242013@33

Distribution pattern

USA nationwide

drug · product 51 of 86

GLYCINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-964-2013
Recall number
D-964-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03012013@16

Distribution pattern

USA nationwide

drug · product 52 of 86

GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-965-2013
Recall number
D-965-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03072013@18, 04152013@27, 04112013@12

Distribution pattern

USA nationwide

drug · product 53 of 86

H.C.G. (COMPOUNDED), 5,000, 8, 000, 10,000, 11,000 and 12,000 UNIT VIALS INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-966-2013
Recall number
D-966-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01242013@23, 03132013@20, 04232013@21, 06112013@31, 03282013@24, 02042013@9, 03092013@6, 04122013@10, 04232013@24, 05232013@8, 06192013@26, 07102013@18, 07132013@6, 01072013@3, 02192013@10, 04172013@23, 06192013@28, 07102013@15, 07132013@8, 03232013@4, 03282013@22, 01032013@5, 01182013@24, 02052013@8, 03062013@5, 04122013@4, 04232013@26, 05132013@15, 05232013@5, 06182013@31, 06212013@12, 07132013@4, 03282013@27, 01032013@3, 01242013@16, 02192013@7, 03062013@2, 04122013@8, 04232013@29, 05232013@10, 06112013@28, 06182013@36, and 06242013@21.

Distribution pattern

USA nationwide

drug · product 54 of 86

HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-967-2013
Recall number
D-967-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03262013@26

Distribution pattern

USA nationwide

drug · product 55 of 86

HYALURONIDASE 150 U/ML and 200 U/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-968-2013
Recall number
D-968-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05312013@24, 04242013@34

Distribution pattern

USA nationwide

drug · product 56 of 86

HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-969-2013
Recall number
D-969-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01042013@16, 02262013@21, 03072013@9, 03042013@23, 07022013@36 07252013@18

Distribution pattern

USA nationwide

drug · product 57 of 86

HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-970-2013
Recall number
D-970-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05032013@4, 05222013@13

Distribution pattern

USA nationwide

drug · product 58 of 86

KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-971-2013
Recall number
D-971-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03202013@25

Distribution pattern

USA nationwide

drug · product 59 of 86

L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-972-2013
Recall number
D-972-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02282013@12

Distribution pattern

USA nationwide

drug · product 60 of 86

LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-973-2013
Recall number
D-973-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02262013@10, 03062013@29, 06252013@17, 07092013@18, 05092013@14

Distribution pattern

USA nationwide

drug · product 61 of 86

LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-974-2013
Recall number
D-974-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03192013@28, 02082013@20, 04042013@10

Distribution pattern

USA nationwide

drug · product 62 of 86

LIPOIC ACID 100 MG/ML and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-975-2013
Recall number
D-975-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06272013@25, 04152013@26, 06262013@19

Distribution pattern

USA nationwide

drug · product 63 of 86

MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-976-2013
Recall number
D-976-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01212013@10, 03042013@26, 04032013@23, 04222013@26, 06052013@12, 06122013@27, 07032013@7, 07092013@21, 07152013@40, 07262013@21

Distribution pattern

USA nationwide

drug · product 64 of 86

MAGNESIUM SULFATE 50% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-977-2013
Recall number
D-977-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01082013@14, 02182013@5, and 06052013@29

Distribution pattern

USA nationwide

drug · product 65 of 86

METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-978-2013
Recall number
D-978-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04222013@14, 06052013@35, 07242013@8, 07242013@13, 04082013@11, 04292013@13, 02272013@9, 05212013@39, 03272013@28, 07032013@16, 02272013@8

Distribution pattern

USA nationwide

drug · product 66 of 86

METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-979-2013
Recall number
D-979-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03192013@22, 03192013@24, 02132013@2

Distribution pattern

USA nationwide

drug · product 67 of 86

MIC-CARN + B6/B12/LIDOCAINE 25/50/50/175MCG/1/0.1MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-980-2013
Recall number
D-980-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02142013@6, 05022013@15, 07192013@13

Distribution pattern

USA nationwide

drug · product 68 of 86

MIC-CARN MAX 15/100/50/1 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-981-2013
Recall number
D-981-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03192013@29, 01242013@28, 05212013@23, 06252013@1 and 07022013@27

Distribution pattern

USA nationwide

drug · product 69 of 86

MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-982-2013
Recall number
D-982-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

02082013@10 and 07162013@10

Distribution pattern

USA nationwide

drug · product 70 of 86

NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-983-2013
Recall number
D-983-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03282013@8, 02282013@2, 04012013@22, 05022013@22, 05012013@38

Distribution pattern

USA nationwide

drug · product 71 of 86

NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-984-2013
Recall number
D-984-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07262013@14 and 07262013@12

Distribution pattern

USA nationwide

drug · product 72 of 86

NANDROLONE DECANOATE 100 MG/ML and 200 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-985-2013
Recall number
D-985-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03272013@20, 02272013@17, 03262013@21, 03302013@1, 01152013@12, 02182013@10, 03112013@13, 05062013@13, 05242013@13, 05242013@12, 07012013@32

Distribution pattern

USA nationwide

drug · product 73 of 86

OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-986-2013
Recall number
D-986-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03212013@12, 01112013@20, 03072013@19, and 05082013@27

Distribution pattern

USA nationwide

drug · product 74 of 86

PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-987-2013
Recall number
D-987-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04012013@21, 07252013@15

Distribution pattern

USA nationwide

drug · product 75 of 86

PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-988-2013
Recall number
D-988-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07082013@26

Distribution pattern

USA nationwide

drug · product 76 of 86

POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-989-2013
Recall number
D-989-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05072013@26

Distribution pattern

USA nationwide

drug · product 77 of 86

PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-990-2013
Recall number
D-990-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

06132013@30, 06272013@27

Distribution pattern

USA nationwide

drug · product 78 of 86

PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-991-2013
Recall number
D-991-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05012013@23, 06202013@20

Distribution pattern

USA nationwide

drug · product 79 of 86

PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-992-2013
Recall number
D-992-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

01072013@10, 02262013@5, 06272013@28

Distribution pattern

USA nationwide

drug · product 80 of 86

PUMICE/LIDOCAINE HCL 1.5%/1% INJ SUSP, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-993-2013
Recall number
D-993-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

05202013@20

Distribution pattern

USA nationwide

drug · product 81 of 86

PYRIDOXINE HCL P/F 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-994-2013
Recall number
D-994-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03262013@2, 06252013@16

Distribution pattern

USA nationwide

drug · product 82 of 86

QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-995-2013
Recall number
D-995-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

07162013@27 06262013@38 07102013@27

Distribution pattern

USA nationwide

drug · product 83 of 86

SELENIUM 400 MCG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-996-2013
Recall number
D-996-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03282013@4

Distribution pattern

USA nationwide

drug · product 84 of 86

SERMORELIN ACETATE 10 MG INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-997-2013
Recall number
D-997-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03182013@6, 03282013@26,01142013@2, 01182013@2, 01172013@15, 02192013@3, 03062013@8, 04102013@3, 04262013@11, 05142013@35, 05212013@20, 5212013@17, 05242013@6, 06082013@3, 06072013@10, 06182013@27, 06292013@1, 07132013@2, 07232013@3, 03182013@14

Distribution pattern

USA nationwide

drug · product 85 of 86

SODIUM BICARBONATE PF 8.4% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-998-2013
Recall number
D-998-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

03262013@5, 01212013@6, 01232013@5

Distribution pattern

USA nationwide

drug · product 86 of 86

SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

D-999-2013
Recall number
D-999-2013
Initiated
July 26, 2013
Classification
Class II
Status
Terminated
Quantity
N/A

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Code information

04152013@28

Distribution pattern

USA nationwide