Tri-Mix Injectable Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Tri-Mix T-106 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential sterility issues.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The affected product is a 300 ml injectable solution. All lots distributed between November 2014 and May 2015 are included in this recall. The specific lot codes and dates are 02032015@57 (8/2/2015), 02112015@14 (8/10/2015), 04012015@17 (9/28/2015), 04272015@49 (10/24/2015), and 05052015@12 (11/1/2015). The product was distributed nationwide.
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 T-106 (30 mg/1 mg/25 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 (11)
- All lots distributed between November 2014 and May 2015
- 02032015@57
- 8/2/2015
- 02112015@14
- 8/10/2015
- 04012015@17
- 9/28/2015
- 04272015@49
- 10/24/2015
- 05052015@12
- 11/1/2015
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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