Testosterone Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone 30 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in a sterile injectable product.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone 30 mg, Sterile Pellets. The recall covers 24-pellet packages distributed nationwide between November 2014 and May 2015. Specific lot codes identified in the recall include 02192015@41 and 8/18/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns about the assurance of sterility and potentially impact the overall quality of the product.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Affected units
- 24
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 (3)
- All lots distributed between November 2014 and May 2015
- 02192015@41
- 8/18/2015
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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