Tri-Mix ST4 Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST4 Injectable due to GMP violations that may impact sterility. The recall covers lots distributed nationwide from November 2014 to May 2015.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterility assurance issues in injectable products which carry significant risk.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, 10 ml vials. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility assurance.
The affected product was distributed nationwide. The recall includes all lots distributed between November 2014 and May 2015, specifically identified by the code 01272015@29 with a date of 7/26/2015.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — 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 (3)
- All lots distributed between November 2014 and May 2015
- 01272015@29
- 7/26/2015
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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