Drug recall D-0977-2018
Product
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.
Lots and codes
Lot #: JKS0280A, Exp. 06/2019
Recall details
- Recalling firm
- Sun Pharmaceutical Industries, Inc., Cranbury, NJ
- Quantity
- 5215 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 12, 2018
- Terminated
- March 11, 2019
Related products
- Testosterone Cypionate – drug information
- NDC 62756-015 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-016 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Sun Pharmaceutical Industries, Inc.
- NDC 62756-017 Testosterone Cypionate · Testosterone Cypionate 100 mg/mL · Sun Pharmaceutical Industries, Inc.