Testosterone Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Testosterone 200 mg sterile pellets due to 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 the rubric specifies that FDA Class II recalls with potential for serious harm (such as sterility failures in injectable/implantable drugs) are rated as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling 510 Testosterone 200 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 affected lots were distributed nationwide between November 2014 and May 2015. The recall covers specific lot codes and expiration dates listed in the official notice, including lots distributed as late as October 2015.
Consumers who have these specific lots of Testosterone 200 mg sterile pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Testosterone Pellets
- Affected units
- 510
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
- 12122014@8
- 6/10/2015
- 12042014@47
- 6/2/2015
- 01122015@54
- 7/11/2015
- 04142015@82
- 10/11/2015
- 01072015@32
- 7/6/2015
- 01192015@17
- 7/18/2015
- 02042015@43
- 8/3/2015
- 02232015@35
- 8/22/2015
- 02272015@30
- 8/26/2015
- 02272015@19
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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