FDA Recalls Tri-Mix Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Tri-Mix injectable products because FDA inspections found GMP violations that may affect 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which aligns with the rubric for Severe recalls involving significant potential for harm.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, 5 ml vials. The recall is due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The affected lots were distributed nationwide between November 2014 and May 2015. The specific lot code provided is 04292015@57, with a date of 10/26/2015. The product is manufactured in Knoxville, TN.
Consumers should check their medication for the specific lot code and contact their healthcare provider or the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, 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 (2)
- All lots distributed between November 2014 and May 2015 04292015@57
- 10/26/2015
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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