Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 18/1/10 Injection 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. The hazard is a documentation issue regarding environmental monitoring, which is a precautionary measure to ensure sterility, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary recalls.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 18/1/10 Injection, a prescription-only medication. The recall involves 555.5 mL of the product, specifically Lot #04062015@30 (Best Use Date: 09/01/2015) and Lot #04172015@20 (Best Use Date: 10/14/2015). The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. The source text states that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap raises concerns about the sterility of the injectable product.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- SIU-Tri-Mix 18/1/10 Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-1540-18
- 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: 04062015@30
- BUD: 09/01/2015
- 04172015@20
- BUD: 10/14/2015
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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