Testosterone Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Testosterone 72.5 mg Pellets due to FDA inspection findings of GMP violations that 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are classified as Severe (Score 4) due to the significant risk of infection or injury, even without reported hospitalizations in this specific text.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 72.5 mg Pellets, Sterile, manufactured in Knoxville, TN. The recall involves 96-pellet units distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations create a lack of assurance regarding the sterility of the product, potentially impacting overall product quality.
Consumers who have these products should stop using them and contact the recalling firm for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Affected units
- 96
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 (9)
- All lots distributed between November 2014 and May 2015
- 01122015@63
- 7/11/2015
- 03162015@9
- 9/12/2015
- 03232015@13
- 9/19/2015
- 05012015@23
- 10/28/2015
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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