Testosterone pellets recalled over a lack of assurance of sterility
Advanced Pharmaceutical Technology is recalling 22,843 TESTO-100 testosterone pellets over a lack of assurance of sterility and potential microbial contamination.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the record cites potential microbial contamination of an implanted pellet, and no injuries are reported.
Plain-English summary
TESTO-100 CIII (testosterone 100 mg), supplied as 10 sterile pellets per carton, manufactured by Advanced Pharmaceutical Technology of Elmsford, New York, under NDC 57377-100-01, is being recalled.
The reason given in the enforcement record is a lack of assurance of sterility: potential microbial contamination of the subcutaneous pellets.
The recall covers 22,843 pellets from lot P-22-3, expiry 06-2027. Distribution covered Georgia, New York, Texas and Puerto Rico, and internationally the United Kingdom, Malta and Greece. The FDA has classified the action as Class II.
A pellet implanted under the skin without assured sterility carries a contamination risk. The enforcement record reports no injuries. Facilities should quarantine the affected lot and follow the firm's instructions.
The recalled product
- Product
- TESTO-100 CIII (testosterone 100 mg), 10 Sterile Pellets per carton, Rx only, Manufactured by: Advanced Pharmaceutical Technology, 132 South Central Avenue, Elmsford, NY 10523, NDC# 57377-100-01
- Manufacturer
- Advanced Pharmaceutical Technology, Inc.
- Category
- Drug — Hormone pellet
- Affected units
- 22,843
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 (2)
- Lot #: P-22-3
- Exp 06-2027
Distribution
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