FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable because an FDA inspection found 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 lack of assurance of sterility in an injectable product, which poses a significant risk of infection or other adverse health consequences, fitting the 'Severe' criteria for significant injury potential or high-risk contamination.
Plain-English summary
The Compounding Pharmacy of America, located in Knoxville, Tennessee, is recalling Tri-Mix T-106/PGE 2 0.1/0.14 Injectable. The product is a 4 ml injectable solution. The recall covers all lots distributed between November 2014 and May 2015, including lot 04172015@7 with an expiration date of 10/14/2015. The product was distributed nationwide.
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 immediately. Patients who have received the product should contact their healthcare provider for guidance. The recalling firm is responsible for managing the recall and providing further information to affected parties.
The recalled product
- Product
- Tri-Mix T-106/PGE 2 0.1/0.14 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 (3)
- All lots distributed between November 2014 and May 2015
- 04172015@7
- 10/14/2015
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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