Recall: D-1123-2019

Class II - Potentially Harmful

Class IIClassification

2019-03-22Initiated

TerminatedStatus

InvaGen Pharmaceuticals, Inc.Firm

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

Presence of Particulate Matter.

Distribution

Nationwide in the U.S.A.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.