Testosterone Cypionate for Injection recalled over manufacturing violations

Recall date

January 14, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sun Pharmaceutical Industries, Inc. recalls Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10…

Recall number

D-0788-2020

FDA classification

Class II

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Product was distributed throughout the United States.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Single Use vial (NDC 62756-015-40) and b) 10 mL Multiple Dose Vial (NDC 62756-016-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India