FDA recall D-0372-2019

Product

Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-931-40 [vial] NDC 47335-931-44 [carton]

Reason for recall

Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2019-01-03

Report date

2019-01-16

Termination date

2021-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0372-2019