PlainRecalls
FDA Drug Moderate Class II Terminated

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Reported: July 13, 2022 Initiated: June 3, 2022 #D-1176-2022

Product Description

Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Reason for Recall

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

Details

Units Affected
27 vials
Distribution
nationwide.
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose vial, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 27 vials.
Why was this product recalled?
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 13, 2022. Severity: Moderate. Recall number: D-1176-2022.