FDA Recalls Tri-Mix Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Tri-Mix T-105 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, which corresponds to a Severe severity score under the rubric for potential serious health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is a 222 ml injectable solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 05052015@11, 02112015@11, 02032015@28, 04012015@16, and 04272015@47.
Consumers and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Tri-Mix T-105 (30 mg/1 mg/10 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
- 05052015@11
- 11/1/2015
- 02112015@11
- 8/10/2015
- 02032015@28
- 8/2/2015
- 04012015@16
- 9/26/2015
- 04272015@47
- 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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