FDA Recalls Tri-Mix Injectable 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable products are categorized as Severe (Score 4) due to the risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (30/1/22) (MFG) Injectable, a 14 ml product manufactured in Knoxville, Tennessee. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 01272015@21 (expiration 7/26/2015) and 03102015@52 (expiration 9/6/2015). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
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 (30/1/22) (MFG) 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 (5)
- All lots distributed between November 2014 and May 2015
- 01272015@21
- 7/26/2015
- 03102015@52
- 9/6/2015
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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