FDA Recalls Testosterone Pellets Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone 70 mg Pellets because an FDA inspection found GMP violations that may affect 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 the hazard involves a lack of assurance of sterility in a sterile drug product, which poses a significant risk of infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 70 mg Pellets, sterile, 60-pellet packages. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 12182014@19, 03192015@38, and 04072015@9.
Consumers should stop using the product and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Hazard
- Affected units
- 60
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 (7)
- All lots distributed between November 2014 and May 2015
- 12182014@19
- 6/16/2015
- 03192015@38
- 9/15/2015
- 04072015@9
- 10/4/2015
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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