FDA Recalls Tri-Mix Injectable Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix ST9C Injectable nationwide 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 agency classification is FDA Class II, and the hazard involves a lack of sterility assurance in an injectable drug, which poses a significant risk of infection or injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, a 101 ml product, due to a lack of assurance of sterility. 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 was distributed nationwide. The recall includes all lots distributed between November 2014 and May 2015. Specific lot codes and dates listed in the recall notice include 02112015@22, 02032015@87, 05062015@3, and 04272015@53.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Tri-Mix ST9C (30 mg/2 mg/120 mcg) 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 (9)
- All lots distributed between November 2014 and May 2015
- 02112015@22
- 8/10/2015
- 02032015@87
- 8/2/2015
- 05062015@3
- 11/2/2015
- 04272015@53
- 10/24/2015
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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