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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65019

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

Open FDA event record

Event summary

Timeline bucket
April 22, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nora Apothecary and Alternative Therapies, Inc.

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

43 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 43

Bimix Inj 30 :1 Syr, 12x1.5 ml syr, 10x1.2 ml syr, 2x2 ml syr, 2x1 ml syr, 12x.05 ml syr Penile Injection,30 and 90 day expiration,

D-453-2013
Recall number
D-453-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
5

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 2 of 43

Bimix Inj 30:0.5 MDV, 5 ml syr Penile Injection, 90 day expiration,

D-454-2013
Recall number
D-454-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
5

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 3 of 43

Bimix Inj 30:1 MDV: 5ml, 10 ml, 3x10ml, 2x10ml Penile Injection, 30 and 90 day expiration,

D-455-2013
Recall number
D-455-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
128

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 4 of 43

Papaverine Inj 30mg/ml Syr, 5mlsyr, 10mlsyr,10x0.95mlsyr Penile Injection, 90 day expiration,

D-456-2013
Recall number
D-456-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
8

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 5 of 43

PGE-1 Inj 10mcg/ml MDV, 5ml Penile Injection, 90 day expiration,

D-457-2013
Recall number
D-457-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 6 of 43

PGE-1 Inj 20mcg/ml MDV: 5ml, 7ml, 10ml, 20ml Penile Injection, 90 day expiration,

D-458-2013
Recall number
D-458-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
37

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 7 of 43

PGE-1 Inj 30mcg/ml MDV, 7 ml Penile Injection, 90 day expiration,

D-459-2013
Recall number
D-459-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 8 of 43

PGE-1 Inj 40mcg/ml MDV, 5 ml Penile Injection, 90 day expiration,

D-460-2013
Recall number
D-460-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 9 of 43

Trimix Inj 30:1:10 MDV, 5 ml Penile Injection, 30 and 90 day expiration,

D-461-2013
Recall number
D-461-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 10 of 43

Trimix Inj 30:1:20 MDV: 5 ml, 10 ml, 2x5 ml Penile Injection, 30 and 90 day expiration,

D-462-2013
Recall number
D-462-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
72

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 11 of 43

Trimix Inj 30:1:40 MDV, 5 ml Penile Injection, 30 and 90 day expiration,

D-463-2013
Recall number
D-463-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 12 of 43

Trimix Inj 30:3:5 MDV, 10ml Penile Injection, 90 day expiration,

D-464-2013
Recall number
D-464-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
1

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 13 of 43

Trimix Inj 4.25ml Form MDV Penile Injection, 90 day expiration,

D-465-2013
Recall number
D-465-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 14 of 43

Super Trimix #1 Inj MDV, 12 ml Penile Injection, 90 day expiration,

D-466-2013
Recall number
D-466-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
1

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 15 of 43

Vancomycin Opth Soln 25mg/ml PF, 10ml Opthalmic Soln, 10 day expiration,

D-467-2013
Recall number
D-467-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 16 of 43

Vancomycin Opth Soln 30mg/ml PRES, 10ml Opthalmic Soln, 30 day expiration,

D-468-2013
Recall number
D-468-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 17 of 43

Vancomycin Opth Soln14mg/ml PF, 10ml Opthalmic Soln, 30 day expiration,

D-469-2013
Recall number
D-469-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
1

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 18 of 43

Tobramycin Opth Soln 14mg/ml, 7ml Opthalmic Soln, 10 day expiration,

D-470-2013
Recall number
D-470-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 19 of 43

Tobramycin Opth Soln 13mg/ml, 7ml Opthalmic Soln, 10 day expiration,

D-471-2013
Recall number
D-471-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 20 of 43

Chlorhexidine Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,

D-472-2013
Recall number
D-472-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
1

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 21 of 43

Dexamethasone Opth Soln 0.1% PF, 10 ml Opthalmic Soln, 30 day expiration,

D-473-2013
Recall number
D-473-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
7

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 22 of 43

PHMB Opth Soln 0.02%, 10 ml Opthalmic Soln, 30 day expiration,

D-474-2013
Recall number
D-474-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 23 of 43

Folic Acid Inj 5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,

D-475-2013
Recall number
D-475-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 24 of 43

HCG Inj 1000un/ml MDV: 4ml, 8 ml Subcutaneous, 30 day expiration,

D-476-2013
Recall number
D-476-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
3

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 25 of 43

HCG Inj 1200un/ml MDV, 10 ml Subcutaneous, 30 day expiration,

D-477-2013
Recall number
D-477-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
3

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 26 of 43

HCG Inj 1250 un/ml MDV, 4 ml Subcutaneous, 30 day expiration,

D-478-2013
Recall number
D-478-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 27 of 43

HCG Inj 500un/ml MDV, 5 ml Subcutaneous, 30 day expiration,

D-479-2013
Recall number
D-479-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 28 of 43

Hydroxycobalamin Inj 1000mcg/ml MDV: 10 ml, 15 ml, 20 ml, 30 ml Subcutaneous, 90 day expiration,

D-480-2013
Recall number
D-480-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
7

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 29 of 43

Hydroxycobalamin Inj 1 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

D-481-2013
Recall number
D-481-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 30 of 43

Hydroxycobalamin Inj 2500 mcg/ml MDV, 2x30ml Subcutaneous, 90 day expiration,

D-482-2013
Recall number
D-482-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 31 of 43

Methylcobalamin Inj 1mg/ml MDV, 10 ml, 15 ml, 20 ml, 30 ml, 4x30 ml Subcutaneous, 90 day expiration,

D-483-2013
Recall number
D-483-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
14

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 32 of 43

Methylcobalamin Inj 5mg/ml MDV: 5 ml, 10 ml, 12 ml, 20 ml Subcutaneous, 90 day expiration,

D-484-2013
Recall number
D-484-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
11

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 33 of 43

Methylcobalamin 5mg/ml Inj Syr, 10x0.4syr Subcutaneous, 90 day expiration,

D-485-2013
Recall number
D-485-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 34 of 43

Methylcobalamin Inj 2.5mg/ml MDV, 10 ml Subcutaneous, 90 day expiration,

D-486-2013
Recall number
D-486-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
3

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 35 of 43

Methylcobalamin Inj 25mg/ml Syr: 8x0.06mlsyr, 10x0.06 ml syr, 12x0.06 ml syr Subcutaneous, 30 and 90 day expiration,

D-487-2013
Recall number
D-487-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
5

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 36 of 43

Hydroxyprogesterone Inj 250mg/ml MDV, 5 ml Intramuscular, 30 day expiration,

D-488-2013
Recall number
D-488-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
5

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 37 of 43

Renacidin Irrigation: 1000 ml,1120ml Bladder Irrigation, 30 day expiration,

D-489-2013
Recall number
D-489-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 38 of 43

Gentamicin 24mg/60ml Irrigation, 15x60ml Syr Irrigation, 14 day expiration,

D-490-2013
Recall number
D-490-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 39 of 43

Glutathione 200mg/ml Inj SDV: 3x50ml 14 day expiration, 1x50ml 21 day expiration

D-491-2013
Recall number
D-491-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 40 of 43

M.I.C.+B12 Inj MDV: 3x50ml, 4x50 ml 90 day expiration,

D-492-2013
Recall number
D-492-2013
Initiated
April 22, 2013
Classification
Class II
Status
Terminated
Quantity
2

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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 41 of 43

Lidocaine 2% Inj MDV, 20 ml 30 day expiration,

D-493-2013
Recall number
D-493-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 42 of 43

Meperidine 100mg/ml MDV, 5ml 90 day expiration,

D-494-2013
Recall number
D-494-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide

drug · product 43 of 43

Pyridoxine 100mg/ml Inj MDV, 1X30 ml 30 day expiration,

D-495-2013
Recall number
D-495-2013
Initiated
April 22, 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 inspection findings resulted in concerns regarding quality control processes.

Code information

All products within their expiration date including those dated 90 days prior to April 19, 2013 (Jan. 2013 to April 19, 2013).

Distribution pattern

Nationwide