Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized…

Class I — High risk. Reasonable probability of serious harm or death.

Recalling firm

Sun Pharmaceutical Industries, Inc.

NDC code

47335-931-40

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0372-2019

Other Vecuronium recalls

See all

Class II · Moderate risk Terminated Jul 17, 2023

vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego…

Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles

Central Admixture Pharmacy Services Inc D-1048-2023

Class II · Moderate risk Terminated Apr 13, 2022

Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03

Reason cGMP deviations: Temperature abuse

Mckesson Medical-Surgical Inc. Corporate Office NDC 0703-2914-03 D-1079-2022

Class II · Moderate risk Terminated Jul 29, 2021

Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01

Reason Lack of Assurance of Sterility

Teva Pharmaceuticals USA NDC 0703-2914-01 D-0735-2021

Class II · Moderate risk Terminated Feb 10, 2021

Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10…

Reason Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of…

Teva Pharmaceuticals USA NDC 0703-2914-01 D-0279-2021

Class I · High risk Terminated Jan 3, 2019

Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured…

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

Sun Pharmaceutical Industries, Inc. D-0373-2019