Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns
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 and involves a sterile injectable product where sterility assurance is compromised, meeting the rubric criteria for Severe severity.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen. The product is a 19 ml injectable solution distributed nationwide. The recall involves all lots distributed between November 2014 and May 2015, specifically lot 01202015@49, 04082015@12, and 04282015@6.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Tri-Mix (25/2.5/10) 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 (7)
- All lots distributed between November 2014 and May 2015
- 01202015@49
- 7/19/2015
- 04082015@12
- 10/5/2015
- 04282015@6
- 10/25/2015
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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