Tri-Mix Injectable Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Tri-Mix T-50/PGE 1 0.14/0.08 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 are assigned a score of 4 (Severe), particularly when involving sterility assurance issues in injectable products where hospitalization or significant injury risks are inherent to the hazard type, even if not explicitly reported in this specific text snippet.
Plain-English summary
The Compounding Pharmacy of America, located in Knoxville, Tennessee, is recalling Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, 8 ml vials. The recall covers all lots distributed nationwide between November 2014 and May 2015, including lot 001072015@39 dated July 6, 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. The agency has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients who have received this medication should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Tri-Mix T-50/PGE 1 0.14/0.08 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 (3)
- All lots distributed between November 2014 and May 2015
- 001072015@39
- 7/6/2015
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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