Tri-Mix Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable products are classified as Severe (Score 4).
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen. The product is a 25 ml total volume injectable manufactured in Knoxville, TN, and distributed nationwide.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. This lack of assurance of sterility is the primary reason for the recall.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 05072015@6 (dated 11/3/2015) and 05052015@77 (dated 11/1/2015). Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, 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 (5)
- All lots distributed between November 2014 and May 2015
- 05072015@6
- 11/3/2015
- 05052015@77
- 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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