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 and involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix (37.5/2/20) (MFG) Injectable, a 38 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 recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates included in the recall are 01152015@60, 02272015@34, and 04012015@27. The agency classification for this recall is Class II.
Patients who have received this product should consult their healthcare provider for guidance on next steps. The source text does not report any specific illnesses or injuries associated with the recalled product.
The recalled product
- Product
- Tri-Mix (37.5/2/20) (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 (7)
- All lots distributed between November 2014 and May 2015
- 01152015@60
- 7/14/2015
- 02272015@34
- 8/26/2015
- 04012015@27
- 9/28/2015
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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