D-0977-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 1, 2018
- Initiation Date
- July 12, 2018
- Termination Date
- March 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5215 units
Product Description
Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40
Reason for Recall
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: JKS0280A, Exp. 06/2019