PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 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 69097-536-37.

Reported: April 24, 2019 Initiated: March 22, 2019 #D-1125-2019

Product Description

Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 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 69097-536-37.

Reason for Recall

Presence of Particulate Matter.

Details

Units Affected
75968 vials
Distribution
Nationwide in the U.S.A.
Location
Central Islip, NY

Frequently Asked Questions

What product was recalled?
Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 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 69097-536-37.. Recalled by InvaGen Pharmaceuticals, Inc.. Units affected: 75968 vials.
Why was this product recalled?
Presence of Particulate Matter.
Which agency issued this recall?
This recall was issued by the FDA Drug on April 24, 2019. Severity: Moderate. Recall number: D-1125-2019.