CLASS II Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial recalled
Olympia Compounding Pharmacy is recalling Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial, distributed nationwide in the US. The recall was initiated on 9 May 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0936-2022
- FDA event ID
- 90204
- Recalling firm
- Olympia Compounding Pharmacy, Orlando, FL
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 9 May 2022
- FDA classified
- 25 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 9 May 2022 | Recall initiated by company | |
| 25 May 2022 | Classified by FDA | +16 days |
| 1 Jun 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose 10mL vial, NDC 73198-0051-10; b) Multi-Dose 30mL vial, NDC 73198-0051-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
Where it was distributed
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Questions about this recall
Is Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial recalled?
Yes. Olympia Compounding Pharmacy recalled Methylcobalamin 5 mg/mL, Packaged as a) Multi-Dose vial on 9 May 2022. The recall is Class II and its status is Completed. Recall number D-0936-2022.
Why was it recalled?
Lack of assurance of sterility.
Which lots are affected?
Lots: L24122, L24C22, L24B22 BUD: 6/22/2022, A24124-22 BUD: 7/24/2022, A24225-22 BUD: 7/25/2022, A24026-22 BUD: 7/26/2022, A24027-22 BUD: 7/27/2022, A24C31-22, A24B31-22 BUD: 7/31/2022
Where was it sold?
Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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