Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIH-Testosterone Cypionate Injection because proper environmental monitoring documentation is missing, raising concerns about 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 due to a documentation gap regarding environmental monitoring, which is a voluntary precautionary measure without reported illnesses or injuries.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIH-Testosterone Cypionate 200 mg/mL Injection, 10 mL Vials. The recall affects approximately 1,200.4 mL of the medication distributed in Oklahoma. Specific lots involved include 04142015@5 (Best Use Date 8/12/2015), 04032015@23 (Best Use Date 7/2/2015), and 04242015@28 (Best Use Date 8/22/2015).
The recall was initiated due to a lack of assurance of sterility. The firm identified that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap prevents verification that the sterile conditions required for compounding were maintained.
Consumers and healthcare providers who have this product should stop using it and contact The Apothecary Shoppe LLC or their healthcare provider for instructions on return or disposal. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- SIH-Testosterone Cyp. 200 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2829-34
- 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 (6)
- Lot #: 04142015@5
- BUD 8/12/2015
- 04032015@23
- BUD 7/2/2015
- 04242015@28
- BUD 8/22/2015
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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