Tri-Mix SUPER Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix SUPER 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 sterile injectable product where sterility assurance is compromised, posing a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen. The recall involves 161 ml of product distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the official recall documentation.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and potentially impact the overall quality of the product. The agency has classified this as a Class II recall.
Patients who have received this medication should consult their healthcare provider for guidance on next steps. Consumers should not use the recalled product and should contact their pharmacist or the recalling firm for further information.
The recalled product
- Product
- Tri-Mix SUPER (28 mg/0.9 mg/37 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 (16)
- All lots distributed between November 2014 and May 2015
- 01202015@30
- 7/19/2015
- 01262015@22
- 7/25/2015
- 02092015@14
- 7/1/2015
- 02192015@12
- 8/18/2015
- 03202015@86
- 9/16/2015
- 03232015@25
- 9/19/2015
- 04282015@14
- 10/25/2015
- 04282015@18
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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