FDA recall D-0611-2017

Sun Pharmaceutical Industries, Inc. · Class II · drug

Product

Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramuscular Use Only, Rx Only, Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40

Reason for recall

Presence of Particulate Matter

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2017-03-15
Report date
2017-03-29
Termination date
2018-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0611-2017