Apothecary Shoppe Recalls Papaverine and Phentermine Injection for Sterility Concerns
The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentermine Injection due to a lack of documentation proving proper environmental monitoring 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 due to a documentation deficiency regarding environmental monitoring. As no illnesses or injuries are reported and the hazard is theoretical based on missing records, it fits the Moderate severity criteria for voluntary precautionary recalls.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling 55 mL of SIU-Papav/Phent 30/1 mg Injection. The affected product is identified by Lot # 04162015@30 and has a beyond-use date of October 13, 2015. The recall is limited to distribution within Oklahoma.
The recall was initiated due to a lack of assurance of sterility. Specifically, the firm could not provide documentation of proper environmental monitoring during the time the medication was produced. This documentation gap raises concerns about the sterility of the injectable product.
Patients who have received this specific lot of medication should contact their healthcare provider for guidance. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SIU-Papav/Phent 30/1 mg Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-6830-10
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Injectable
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 #: 04162015@30
- BUD 10/13/2015
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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