Testosterone Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone 87.5 mg Sterile Pellets because FDA inspections identified 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. According to the rubric, FDA Class II recalls involving significant quality issues like sterility assurance are categorized as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling 265 Testosterone 87.5 mg Sterile Pellets. 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 was distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates are listed in the official recall documentation.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Hazard
- Affected units
- 265
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 (20)
- All lots distributed between November 2014 and May 2015
- 03022015@60
- 8/29/2015
- 12042014@65
- 6/2/2015
- 12182014@39
- 6/16/2015
- 01152015@37
- 7/14/2015
- 01052015@1
- 7/4/2015
- 02052015@50
- 8/4/2015
- 02132015@14
- 8/12/2015
- 03162015@14
- 9/12/2015
- 03252015@14
- 9/21/2015
- 04222015@44
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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