US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 7, 2013 (13 years ago)

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: product was not manufactured under current good manufacturing practices which contributed to Failed Impurities/Degradation Specifications as a high out of specification impurity result was detected during routine quality testing of stability samples.

What was recalled

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Pharmaceuticals; Made in Turkey, NDC 25021-657-10.

Recalling firm
Sagent Pharmaceuticals Inc
NDC code
25021-657-10
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-605-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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