Testosterone Pellets Recalled for Potential Sterility Assurance Issues
The Compounding Pharmacy of America is recalling Testosterone 50 mg Pellets 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 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, Inc. is recalling Testosterone 50 mg Pellets, Sterile. The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of 216 pellets per unit. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and distribution dates are listed in the official recall documentation.
Consumers who have purchased this product should contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Sterile
- Affected units
- 216
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 (19)
- All lots distributed between November 2014 and May 2015
- 12032014@47
- 6/1/2015
- 12052014@36
- 6/3/2015
- 12192014@33
- 6/17/2015
- 01202015@53
- 7/19/2015
- 01062015@58
- 7/5/2015
- 02122015@40
- 8/11/2015
- 03022015@15
- 8/29/2015
- 03252015@22
- 9/21/2015
- 05082015@6
- 11/4/2015
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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