Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Testosterone 12.5 mg sterile 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are assigned a score of 4 (Severe) due to the risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 12.5 mg, Sterile Pellets. 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 specific issue is a lack of assurance of sterility.
The affected product consists of 144 pellets per unit. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; and 04302015@53, 10/27/2015. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Affected units
- 144
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
- 11262014@67
- 5/25/2015
- 03022015@70
- 8/29/2015
- 01052015@50
- 7/4/2015
- 02052015@72
- 8/4/2015
- 04302015@53
- 10/27/2015
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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