Testosterone Sterile Pellets Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone 70 mg sterile 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 injectable product where sterility assurance is compromised, posing a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 70 mg, Sterile Pellets, 60-pellet packages. 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 dates include 12182014@19 (6/16/2015), 03192015@38 (9/15/2015), and 04072015@9 (10/4/2015).
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroids
- 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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