Apothecary Shoppe Recalls S-Methylcobalamin Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling S-Methylcobalamin 5000 mcg/mL Injection in 750 mL containers due to a lack of assurance of sterility.
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. The hazard is a lack of assurance of sterility due to documentation issues, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported illness.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling S-Methylcobalamin 5000 mcg/mL Injection, Rx Only, in 750 mL containers. The recall is limited to Lot # 05012015@4 with a beyond-use date of 10/28/2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. This issue arose because there was a lack of documentation of proper environmental monitoring during the time the medication was produced.
Consumers and healthcare providers who have this specific lot of S-Methylcobalamin Injection should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- S-Methylcobalamin 5000 mcg/mL Inj., Rx Only, 750 mL Container, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Injectable
- Hazard
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 #: 05012015@4
- BUD 10/28/2015
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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