Apothecary Shoppe Recalls SIU-Tri-Mix Injectable Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 17/0.6/5.7 Injectable in Oklahoma due to lack of assurance of sterility from missing environmental monitoring documentation.
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-Tri-Mix 17/0.6/5.7 Injectable, a prescription-only 5 mL vial, in Oklahoma. The recall is due to a lack of assurance of sterility resulting from the lack of documentation of proper environmental monitoring during the time the medication was produced.
The affected product is identified by Lot # 04162015@36 with a beyond-use date of 10/13/2015. The product was distributed in Oklahoma.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- SIU-Tri-Mix 17/0.6/5.7 Injectable, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-2348-22
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — 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 #: 04162015@36
- 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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