Apothecary Shoppe Recalls SIU-Phent Injection Due to Sterility Documentation Issues
The Apothecary Shoppe is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection vials because proper environmental monitoring documentation was missing during production.
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, and the hazard is a documentation issue regarding environmental monitoring rather than a confirmed contamination or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection, a prescription-only medication packaged in 10 mL vials. The recall is limited to Lot # 03172015@39, which has a beyond-use date of 07/15/2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. Specifically, the firm identified a lack of documentation confirming that proper environmental monitoring was conducted during the time the medication was produced. This documentation gap prevents verification that the sterile conditions required for the product were maintained.
Consumers and healthcare providers who have this specific lot of SIU-Phent .8/PGE1 20 mcg/mL Injection should stop using it and contact The Apothecary Shoppe LLC or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- SIU-Phent .8/PGE1 20 mcg/mL Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2557-43
- 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 #: 03172015@39
- BUD 07/15/2015
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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