Tri-Mix Injectable Recalled for Potential Sterility and Quality Issues
The Compounding Pharmacy of America is recalling Tri-Mix injectable vials because FDA inspections found GMP violations that may affect sterility and product quality.
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, which corresponds to a Severe rating (score 4) under the rubric, particularly given the risk of sterility failure in an injectable drug.
Plain-English summary
The Compounding Pharmacy of America is recalling 13 ml vials of Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen. The product was distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, 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
- 01262015@6
- 7/25/2015
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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