FDA recall D-1176-2022

Product

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.

Distribution

nationwide.

Key facts

Status

Terminated

Initiation date

2022-06-03

Report date

2022-07-13

Termination date

2023-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1176-2022