FDA Recall D-0372-2019
Sun Pharmaceutical Industries, Inc. · Cranbury, NJ
Class I — life-threatening Terminated 1035 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0372-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-01-03
- Classified by FDA Center
- 2019-01-14
- FDA published
- 2019-01-16
- Terminated
- 2021-11-03
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Firm location
- Cranbury, NJ
Drug identification
- Brand name(s)
- VECURONIUM BROMIDE
- Generic name(s)
- VECURONIUM BROMIDE
- Manufacturer(s)
- Sun Pharmaceutical Industries, Inc.
- NDC(s)
47335-931, 47335-932- Route(s)
- INTRAVENOUS