Testosterone Injection Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone Tri-Blend injections due to FDA inspection findings regarding sterility assurance and GMP violations.
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, and the hazard 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 Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection. The recall involves all lots distributed between November 2014 and May 2015. The product was distributed nationwide.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. Specifically, there is a lack of assurance of sterility for the affected units.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, 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
- 01122015@49
- 7/11/2015
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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