Injectable Folic Acid and Hydroxocobalamin Recalled Due to Sterility Concerns
Olympia Compounding Pharmacy is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL injectable due to lack of sterility assurance. The affected vials were distributed nationwide, in Puerto Rico, and the US Virgin Islands.
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 sterility assurance failure on injectable medication. While sterility issues on injectables pose serious risk of infection, no illnesses or injuries are reported in the source. The recall meets the rubric criterion for Score 3: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmaceuticals is recalling 2,441 vials of Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL multi-dose 30 mL vials (NDC 73198-0112-30). These are prescription injectable products used to supplement folic acid and vitamin B12 (hydroxocobalamin).
The recall was initiated due to lack of assurance of sterility. Sterility is critical for injectable medications; a non-sterile injectable could introduce harmful bacteria or microorganisms directly into the bloodstream, potentially causing serious infections or other serious health complications.
The recalled vials were distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. The affected lots are L24007 (beyond-use date 6/7/2022) and B24017-22 (beyond-use date 8/17/2022). The manufacturer is located at 6700 Conroy Road, Suite 155, Orlando, Florida 32835.
The recalled product
- Product
- Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0112-30
- Category
- Drug — Injectable
- Hazard
- Affected units
- 2,441
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 (2)
- Lots: L24007 BUD: 6/7/2022
- B24017-22 BUD: 8/17/2022
Distribution
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.
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