Testosterone Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Testosterone 75 mg Pellets 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 involves a sterile product where sterility assurance is compromised, posing a risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling 192 Testosterone 75 mg Pellets, Sterile, manufactured in Knoxville, Tennessee. 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 affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes and distribution dates are listed in the recall documentation, including lots distributed as late as October 2015. The recall is classified as FDA Class II.
Consumers who have these products should stop using them 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 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Hazard
- Affected units
- 192
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 (17)
- All lots distributed between November 2014 and May 2015
- 05072015@42
- 11/3/2015
- 12292014@9
- 6/27/2015
- 12032014@12
- 6/1/2015
- 12042014@73
- 6/2/2015
- 02272015@63
- 8/26/2015
- 05042015@44
- 10/31/2015
- 03302015@9
- 9/26/2015
- 04092015@46
- 10/6/2015
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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