Apothecary Shoppe Recalls SIU-Tri-Mix Due to Sterility Documentation Gaps
The Apothecary Shoppe is recalling SIU-Tri-Mix 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation gap regarding sterility assurance, which fits the criteria for a moderate, precautionary recall without reported harm.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, a prescription-only medication available in 10 mL vials. The recall involves specific lots distributed in Oklahoma, including lot numbers 05052015@11, 05052015@28, and 03102015@38.
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 standards.
Patients who have received this medication should contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13389-1152-36
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Compounded Medication
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 (5)
- Lot #s: 05052015@11
- 05052015@28
- BUD 11/1/2015
- 03102015@38
- BUD 7/8/2015
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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