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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65125

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

Open FDA event record

Event summary

Timeline bucket
May 02, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
THE COMPOUNDING SHOP, 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

25 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 25

Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

D-548-2013
Recall number
D-548-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
19 vials of 10ml

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 2 of 25

Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL

D-549-2013
Recall number
D-549-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
80 vials of 4mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 3 of 25

Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

D-550-2013
Recall number
D-550-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial of 22mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 4 of 25

Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

D-551-2013
Recall number
D-551-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial of 20mL and 1 vial of 40mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 5 of 25

Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

D-552-2013
Recall number
D-552-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
3 vials of 45mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 6 of 25

Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-553-2013
Recall number
D-553-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
20 vials of 5mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 7 of 25

Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-554-2013
Recall number
D-554-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
2 vials of 100mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 8 of 25

Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-555-2013
Recall number
D-555-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
41 vials of 2mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 9 of 25

Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-556-2013
Recall number
D-556-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 10 of 25

Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-557-2013
Recall number
D-557-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
43 vials of 250mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 11 of 25

Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-558-2013
Recall number
D-558-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
7 vials of 50mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 12 of 25

Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-559-2013
Recall number
D-559-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
55 vials of 100mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 13 of 25

Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-560-2013
Recall number
D-560-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
4 vials of 10mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 14 of 25

Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-561-2013
Recall number
D-561-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
44 vials of 50mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 15 of 25

Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-562-2013
Recall number
D-562-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
2 vials of 250mL and 26 vials of 100mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 16 of 25

Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-563-2013
Recall number
D-563-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
78 vials of 500ml and 92 vials of 100mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 17 of 25

B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-564-2013
Recall number
D-564-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
56 vials of 50mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 18 of 25

Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-565-2013
Recall number
D-565-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
32 vials of 50mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 19 of 25

MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-566-2013
Recall number
D-566-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
14 vials of 30mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 20 of 25

Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-567-2013
Recall number
D-567-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 21 of 25

Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-568-2013
Recall number
D-568-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial of 40mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 22 of 25

Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-569-2013
Recall number
D-569-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
1 vial of 40ml

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 23 of 25

Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL

D-570-2013
Recall number
D-570-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
5 vials of 50mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 24 of 25

MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

D-571-2013
Recall number
D-571-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
10 vials of 30 mL each

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine

drug · product 25 of 25

Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL

D-572-2013
Recall number
D-572-2013
Initiated
May 02, 2013
Classification
Class II
Status
Terminated
Quantity
4 vials of 5mL and 22 vials of 10mL

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 Lots

Distribution pattern

Florida, California, Minnesota, and Maine