Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling SIU-Tri-Mix 18/1/20 Injection because documentation for environmental monitoring during production was missing.
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 temporary or medically reversible adverse health consequence. The hazard is a lack of documentation regarding sterility, which is a significant quality control issue but does not explicitly report injuries or deaths in the source text.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 18/1/20 Injection, a prescription-only medication available in 10 mL vials. The recall affects 55 mL of the product, specifically Lot # 04202015@34 with a beyond-use date of 10/17/2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. The firm identified that proper documentation of environmental monitoring was missing during the time the medication was produced. This documentation gap prevents verification that the product met sterility requirements.
Consumers and healthcare providers who have this specific lot of SIU-Tri-Mix 18/1/20 Injection should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- SIU-Tri-Mix 18/1/20 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1563-48
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Injection
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 #: 04202015@34
- BUD 10/17/2015
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.
See all 28 products in this recall →Related recalls
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