Testosterone Cypionate Injection Recalled Without Approved Application
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200 (Testosterone Cypionate Injection USP, 200mg/ml) because it was marketed without an approved NDA or ANDA.
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: This is an FDA Class II recall. Marketing a drug without an approved NDA/ANDA is a serious regulatory violation that poses a significant health risk because the product has not undergone FDA review for safety and efficacy, meeting the threshold for Severe classification.
Plain-English summary
Advanced Pharmaceutical Technology, Inc. is recalling TESTO-200, Testosterone Cypionate Injection USP (2000mg/10ml, 200mg/ml) distributed in New York and New Jersey. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The affected product includes 26 vials with Lot P-24-1 and expiration date 02/28/2027. The product is supplied in 10ml multidose vials for intramuscular injection and is prescription-only.
Patients currently using this product should consult their healthcare provider before making any changes to their treatment. Healthcare providers should contact Advanced Pharmaceutical Technology, Inc. at the address listed for further information about alternative therapeutic options.
The recalled product
- 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
- Manufacturer
- Advanced Pharmaceutical Technology, Inc.
- Hazard
- Affected units
- 26
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-24-1
- Exp. 02/28/2027
Distribution
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