Tri-Mix Injectable Recalled for Potential Sterility Issues
The Compounding Pharmacy of America is recalling Tri-Mix Injectable 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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (20/2.5/20) Injectable, a sterile product intended to be kept frozen. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot codes 03102015@57 and 03092015@71. The total quantity involved is 26 ml.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, 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 (2)
- All lots distributed between November 2014 and May 2015
- 03102015@57 9/6/2015 03092015@71 9/5/2015
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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