Testosterone Cypionate Injection Recalled Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml injections 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 the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil) Injection, Multi-Dose Vial, Sterile, Room Temperature. The product was distributed nationwide. The recall involves 45 ml units, with all lots distributed between November 2014 and May 2015. Specific lot codes include 04092015@12 and 03122015@13.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, creating a lack of assurance that the product is sterile.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroids
- 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 (5)
- All lots distributed between November 2014 and May 2015
- 04092015@12
- 10/6/2015
- 03122015@13
- 9/8/2015
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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