FDA Recalls Tri-Mix ST2 Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST2 Injectable nationwide due to FDA inspection findings of GMP violations that may impact sterility.
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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectables) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, 10 ml vials, distributed nationwide. The recall was initiated following an FDA inspection that identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and potential impacts on product quality.
The recall covers all lots distributed between November 2014 and May 2015. The specific lot code identified in the notice is 04302015@29, with a date of 10/27/2015. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers who have purchased or administered this product should stop using it and contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.
The recalled product
- Product
- Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — 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 (3)
- All lots distributed between November 2014 and May 2015
- 04302015@29
- 10/27/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America 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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