Agency classClass IIOur severity:High FDA (Drugs)·D-0936-2022·Announced 2022-06-01

Methylcobalamin Injectable Recalled for Lack of Sterility Assurance

Olympia Compounding Pharmacy recalls Methylcobalamin 5 mg/mL injectable due to lack of assurance of sterility. Approximately 12,800 vials were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is 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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with lack of assurance of sterility, representing a serious potential risk of contamination for patients. However, the source text does not report any illnesses, injuries, or hospitalizations, making this a precautionary recall based on manufacturing assurance concerns.

Plain-English summary

Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling Methylcobalamin 5 mg/mL, a compounded injectable form of vitamin B12. The product is supplied as multi-dose vials in 10 mL (NDC 73198-0051-10) and 30 mL (NDC 73198-0051-30) formats, for prescription use only. The recall was initiated due to lack of assurance of sterility.

Approximately 12,800 vials were affected and distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. Multiple lot numbers are affected with beyond-use dates ranging from June through July 2022.

The affected lot numbers are: L24122, L24C22, L24B22 (beyond-use date 6/22/2022), A24124-22 (7/24/2022), A24225-22 (7/25/2022), A24026-22 (7/26/2022), A24027-22 (7/27/2022), A24C31-22, and A24B31-22 (7/31/2022).

The recalled product

Product: 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
Manufacturer: Olympia Compounding Pharmacy dba Olympia Pharmacy
Category: Drug — Injectable / Compounded Medication
Hazard: sterility-failure
contamination-risk
infection-risk
Affected units: 12,800

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 53 products in this recall →

Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy

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