Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe is recalling SIU-Tri-Mix Injection Solution because proper environmental monitoring documentation was missing during production.
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 documentation issue regarding sterility assurance without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 6/0.33/3.33 Injection Solution, a prescription-only medication available in 3 mL vials. The recall is limited to Lot # 03192015@27, which has a beyond-use date of July 13, 2015. The product was distributed in Oklahoma.
The recall was initiated due to a lack of assurance of sterility. The firm identified that proper environmental monitoring documentation was missing during the time the medication was produced. This documentation gap prevents verification that the product met sterility standards.
Consumers and healthcare providers in Oklahoma who possess this specific lot of SIU-Tri-Mix Injection Solution should stop using it and contact their pharmacist or The Apothecary Shoppe LLC for further instructions.
The recalled product
- Product
- SIU-Tri-Mix 6/0.33/3.33 Injection Solution, Rx Only, 3 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13429-2007-70
- Manufacturer
- The Apothecary Shoppe LLC
- Category
- Drug — Injectable Solution
- 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 #: 03192015@27
- BUD 07/13/2015
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.
See all 28 products in this recall →Related recalls
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