Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling SIU-Tri-Mix 24/1/20 Injection vials because documentation for environmental monitoring during production was missing, raising concerns about sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a lack of documentation for environmental monitoring, which is a low-risk contamination or documentation issue without reported illnesses.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 24/1/20 Injection, a prescription-only medication packaged in 5 mL vials. The recall is due to a lack of assurance of sterility, specifically because proper documentation of environmental monitoring during the time the medication was produced is missing.
The affected product is identified by Lot # 05052015@39 and has a beyond-use date of November 1, 2015. The medication was distributed in Oklahoma. The recall is classified as Class II by the FDA.
Patients who have received this medication should contact their healthcare provider for further instructions. The recall is voluntary and initiated by the compounding pharmacy.
The recalled product
- Product
- SIU-Tri-Mix 24/1/20 Injection, Rx Only, 5 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1747-39
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded 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 #: 05052015@39
- BUD 11/1/2015
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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