FDA recall D-0977-2018

Product

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

Reason for recall

Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2018-07-12

Report date

2018-08-01

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0977-2018