Drug recall D-1123-2019
Product
Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.
Reason for recall
Presence of Particulate Matter.
Lots and codes
Lot #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020.
Recall details
- Recalling firm
- InvaGen Pharmaceuticals, Inc., Central Islip, NY
- Quantity
- 12234 vials
- Distribution
- Nationwide in the U.S.A.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 22, 2019
- Terminated
- August 16, 2022
Related products
- Testosterone Cypionate – drug information
- NDC 69097-537 Testosterone Cypionate · Testosterone Cypionate 200 mg/mL · Cipla USA Inc.
- NDC 69097-536 Testosterone Cypionate · Testosterone Cypionate 100 mg/mL · Cipla USA Inc.