Hydroxocobalamin B12 Injection Recalled for Sub-Potent Dose
Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1mg/mL injection vials distributed nationwide because the product is sub-potent (below specified strength). The firm initiated this voluntary recall on March 8, 2022.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, and the source text identifies only a sub-potency issue with no reported illnesses or injuries. Class III recalls are typically scored 1 or 2; without evidence of harm, the score is 1.
Plain-English summary
Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling Hydroxocobalamin B12 1mg/mL multi-dose 30 mL vials due to sub-potency. The recalled product is NDC 73198-0080-30, Lot E47025, with expiration date 5/21/22. A total of 1,613 vials were distributed.
The product was distributed nationwide in the USA including Puerto Rico. It is a prescription (Rx only) injection containing hydroxocobalamin, sodium chloride, benzyl alcohol, and sterile water for injection.
The firm initiated this recall voluntarily on March 8, 2022, by letter notification. The FDA classified this as a Class III recall. The recall was terminated on October 4, 2023.
Patients should not use the recalled product and should contact their healthcare provider or pharmacist regarding alternatives. Healthcare providers and patients with questions should contact Olympia Compounding Pharmacy.
The recalled product
- Product
- Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sub-potent
- underdosed-medication
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 (1)
- Lot: E47025 Exp. 5/21/22
Distribution
Distributed nationwide across the United States.
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