Recalls / Class II
Class IID-0531-2025
Product
TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml multidose vial per carton, For intramuscular injection only, Rx Only, ADVANCED PHARMACEUTICAL TECHNOLOGY, INC., 132 South Central Avenue, Elmsford, NY 10523. NDC 57377-200-01
- Affected lot / code info
- Lot P-24-1; Exp. 02/28/2027
Why it was recalled
Marketed Without an Approved NDA/ANDA
Recalling firm
- Firm
- Advanced Pharmaceutical Technology, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 132 S Central Ave, Elmsford, New York 10523-3509
Distribution
- Quantity
- 26 vials
- Distribution pattern
- NY, NJ
Timeline
- Recall initiated
- 2025-05-30
- FDA classified
- 2025-07-16
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0531-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.