Apothecary Shoppe Recalls SIU-Tri-Mix Due to Sterility Documentation Issues
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 20/1 mg/10 mcg/mL 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 illness, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vials. The recall is limited to Lot # 05202015@14 with a beyond-use date of 11/16/2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. This was identified because there was a lack of documentation of proper environmental monitoring during the time the medication was produced.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- SIU-Tri-Mix 20/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2913-85
- Manufacturer
- The Apothecary Shoppe LLC
- 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 #: 05202015@14
- BUD 11/16/2015
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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