FDA Recalls Testosterone and Anastrazole Pellets Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 9 mg Pellets because an FDA inspection found GMP violations that may affect 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, which corresponds to a Severe severity score under the rubric, particularly given the risk of sterility failure in a sterile injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 9 mg Pellets, Sterile. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of 94 pellets per unit. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Affected units
- 94
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 (11)
- All lots distributed between November 2014 and May 2015
- 01292015@32
- 7/28/2015
- 02232015@18
- 5/20/2015
- 02272015@31
- 8/26/2015
- 03092015@23
- 9/5/2015
- 03272015@32
- 9/23/2015
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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