FDA recall D-0242-2021

SUN PHARMACEUTICAL INDUSTRIES INC · Class III · drug

Product

Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONLY 1mL Single-dose vial Distributed by: Sun Pharma Ind. Inc, NJ 08512 Manufactured by: Sun Pharma Ind. Ltd., India NDC 62756-015-40

Reason for recall

Incorrect Labeling: Incorrect lot number on secondary packaging

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2021-01-11
Report date: 2021-02-03
Termination date: 2021-11-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0242-2021