Recall: D-0787-2020

Class II - Potentially Harmful

Class IIClassification

2020-01-14Initiated

TerminatedStatus

Sun Pharmaceutical Industries,Firm

Product

Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India

Reason

cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.

Distribution

Product was distributed throughout the United States.

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