FDA recall D-1154-2022

Product

Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-015-40.

Reason for recall

Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2022-06-10

Report date

2022-06-29

Termination date

2023-07-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1154-2022