Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for 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, which typically involves a reasonable probability of temporary or medically reversible health consequences. The specific issue is a documentation gap regarding environmental monitoring, which is a quality control failure rather than a confirmed contamination event with reported injuries.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 30/1/10 Injection, a prescription-only medication. The recall involves 10 mL vials with NDC 99999-2196-10. The total quantity affected is 67.5 mL.
The recall was initiated due to a lack of assurance of sterility. Specifically, there was a lack of documentation confirming proper environmental monitoring during the time the medication was produced. The affected lots are 04162015@41 with a beyond-use date of 10/13/2015, and 03122015@42 with a beyond-use date of 7/10/2015.
The product was distributed in Oklahoma. Consumers and healthcare providers should stop using the affected medication and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- SIU-Tri-Mix 30/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 99999-2196-10
- 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 (4)
- Lot #s: 04162015@41
- BUD: 10/13/2015
- 03122015@42
- BUD: 7/10/2015
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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