Apothecary Shoppe Recalls S-methylcobalamin Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling S-methylcobalamin 25 mg/mL injection vials because documentation for environmental monitoring during production was missing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a documentation gap regarding sterility assurance rather than a confirmed contamination event.
Plain-English summary
The Apothecary Shoppe LLC is recalling S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vials. The specific product affected is identified by NDC 13861-1701-19, Lot # 04232015@28, with a beyond-use date of 10/20/2015. The quantity involved is 25.3 mL.
The recall was initiated due to a lack of assurance of sterility. This issue arose because proper documentation of environmental monitoring during the time the medication was produced was not available. The FDA has classified this recall as Class II.
The product was distributed in Oklahoma. Consumers and healthcare providers should stop using the affected vials and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- S-methylcobalamin 25 mg/mL (PF) Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1701-19
- Manufacturer
- The Apothecary Shoppe LLC
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)
- Lot #: 04232015@28
- BUD 10/20/2015
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 28 recalled by The Apothecary Shoppe LLC 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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