FDA recall D-1124-2019

Product

Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single 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 69097-537-31.

Reason for recall

Presence of Particulate Matter.

Distribution

Nationwide in the U.S.A.

Key facts

Status

Terminated

Initiation date

2019-03-22

Report date

2019-04-24

Termination date

2022-08-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1124-2019