Apothecary Shoppe Recalls SIU-Tri-Mix Injection Due to Sterility Concerns
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/2/20 Injection in Oklahoma due to a lack of documentation proving proper environmental monitoring during production.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for serious injury or hospitalization (implied by sterility failure in injectable drugs) fall under the Severe category.
Plain-English summary
The Apothecary Shoppe LLC, a compounding pharmacy in Tulsa, Oklahoma, is recalling SIU-Tri-Mix 30/2/20 Injection, a prescription-only medication packaged in 10 mL vials. The recall affects 75 mL of the product distributed in Oklahoma. Specific lots involved include 04082015@45, 04162015@28, and 03182015@9.
The recall was initiated due to a lack of assurance of sterility. The source text indicates that proper environmental monitoring during the time the medication was produced was not documented. This documentation gap raises concerns about the sterility of the product.
Consumers and healthcare providers in Oklahoma who have this specific medication should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II.
The recalled product
- Product
- SIU-Tri-Mix 30/2/20 Inj., Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13861-1398-47
- 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 (6)
- Lot #s: 04082015@45
- BUD 9/1/2015
- 04162015@28
- BUD 10/13/2015
- 03182015@9
- BUD 7/16/2015
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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