D-1153-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 29, 2022
- Initiation Date
- June 3, 2022
- Termination Date
- May 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97,450 vials
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.
Reason for Recall
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
HAC1974A, HAC1978A, Exp 06/2023