Drug recall: Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL
Class II FDA enforcement event 65125. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
THE COMPOUNDING SHOP, INC. started this drug recall on 2 May 2013. The firm address in the FDA record is in St Petersburg, FL. FDA put the recall in Class II. FDA event 65125 has 25 product records. The first FDA enforcement report date is 12 Jun 2013. The record gives the status Terminated, with the termination date 30 Sep 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Florida, California, Minnesota, and Maine
Recalling firm
THE COMPOUNDING SHOP, INC., St Petersburg, FL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
25 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-548-2013 | Methotrexate 25mg/mL Injectable, 10 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL | 19 vials of 10ml | Class II | Terminated | 12 Jun 2013 |
| D-549-2013 | Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding Shop, St. Petersburg, FL | 80 vials of 4mL each | Class II | Terminated | 12 Jun 2013 |
| D-550-2013 | Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | 1 vial of 22mL | Class II | Terminated | 12 Jun 2013 |
| D-551-2013 | Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | 1 vial of 20mL and 1 vial of 40mL | Class II | Terminated | 12 Jun 2013 |
| D-552-2013 | Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL | 3 vials of 45mL | Class II | Terminated | 12 Jun 2013 |
| D-553-2013 | Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 20 vials of 5mL | Class II | Terminated | 12 Jun 2013 |
| D-554-2013 | Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 2 vials of 100mL | Class II | Terminated | 12 Jun 2013 |
| D-555-2013 | Dexamethasone 10 mg/mL Injectable, 2 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 41 vials of 2mL | Class II | Terminated | 12 Jun 2013 |
| D-556-2013 | Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL | Class II | Terminated | 12 Jun 2013 |
| D-557-2013 | Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 43 vials of 250mL each | Class II | Terminated | 12 Jun 2013 |
| D-558-2013 | Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 7 vials of 50mL each | Class II | Terminated | 12 Jun 2013 |
| D-559-2013 | Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 55 vials of 100mL | Class II | Terminated | 12 Jun 2013 |
| D-560-2013 | Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 4 vials of 10mL each | Class II | Terminated | 12 Jun 2013 |
| D-561-2013 | Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 44 vials of 50mL each | Class II | Terminated | 12 Jun 2013 |
| D-562-2013 | Procaine 1% Injectable, 100 mL and 250 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 2 vials of 250mL and 26 vials of 100mL | Class II | Terminated | 12 Jun 2013 |
| D-563-2013 | Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 78 vials of 500ml and 92 vials of 100mL | Class II | Terminated | 12 Jun 2013 |
| D-564-2013 | B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 56 vials of 50mL | Class II | Terminated | 12 Jun 2013 |
| D-565-2013 | Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 32 vials of 50mL | Class II | Terminated | 12 Jun 2013 |
| D-566-2013 | MIC (Methionine, Inositol, and Choline) + B12 25/50/50mg/1000mcg/mL Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 14 vials of 30mL each | Class II | Terminated | 12 Jun 2013 |
| D-567-2013 | Testosterone Cypionate 200 mg/mL Injectable, 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 1 vial of 6mL, 19 vials of 10mL each and 1 vial of 40mL | Class II | Terminated | 12 Jun 2013 |
| D-568-2013 | Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 1 vial of 40mL | Class II | Terminated | 12 Jun 2013 |
| D-569-2013 | Carnosine 5% Opth drop, 40 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 1 vial of 40ml | Class II | Terminated | 12 Jun 2013 |
| D-570-2013 | Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Petersburg, FL | 5 vials of 50mL | Class II | Terminated | 12 Jun 2013 |
| D-571-2013 | MIC (Methionine, Inositol, and Choline) Injectable, 30 mL vials, compounded by The Compounding Shop, St. Petersburg, FL | 10 vials of 30 mL each | Class II | Terminated | 12 Jun 2013 |
| D-572-2013 | Tri-Mix Injections in 5 mL and 10 mL vials (Alprostadil, Phentolamine and Papaverine), compounded by The Compounding Shop, St. Petersburg, FL | 4 vials of 5mL and 22 vials of 10mL | Class II | Terminated | 12 Jun 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2013
- 370
- Share of these events in Class II
- 56%
- Product records in this event
- 25
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report D-548-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 65125. https://recallregister.com/fda/ii/65125/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Florida, California, Minnesota, and Maine
- What quantity of product is in FDA event 65125?
- The event has 25 product records. The first record gives this quantity:
19 vials of 10ml
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2013 have the same class?
- 56% of the 370 drug events that started in 2013 are in Class II.