Sun Pharmaceutical Industries product 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 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Man…

Recall number

D-0373-2019

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 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 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: 47335-932-40 [vial] 47335-932-44 [carton]