Tri-Mix Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Tri-Mix Injectable due to FDA inspection findings of GMP violations that 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 and involves a lack of sterility assurance for an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen. The product is an 8 ml injectable manufactured in Knoxville, Tennessee, and distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically identified by the code 04142015@61 with a date of 10/11/2015.
The recall was initiated due to a lack of assurance of sterility. An FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- Tri-Mix (10/0.174/16) 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 (3)
- All lots distributed between November 2014 and May 2015
- 04142015@61
- 10/11/2015
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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