Vecuronium Bromide for Injection 10 mg* recalled over foreign material

Recall date

January 3, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sun Pharmaceutical Industries, Inc. recalls Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Ma…

Recall number

D-0372-2019

FDA classification

Class I

Brand / firm

Sun Pharmaceutical Industries, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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]