Compounded Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling TRI-MIX injectable vials because FDA inspections found 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 potential sterility issues in injectable products are classified as Severe (Score 4), as they carry a significant risk of harm.
Plain-English summary
The Compounding Pharmacy of America is recalling 13 ml multi-dose vials of TRI-MIX (1/1/40) (MFG) Injectable. The product is sterile and must be kept frozen. The recall covers all lots distributed nationwide between November 2014 and May 2015.
The recall was initiated due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, 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 (3)
- All lots distributed between November 2014 and May 2015
- 03042015@7
- 8/31/2015
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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