D-0372-2019 Class I Terminated
FDA drug recall D-0372-2019 was initiated by Sun Pharmaceutical Industries, Inc. on January 3, 2019 and is designated Class I. Reason for recall: Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. The recall status is terminated (terminated November 3, 2021). Affected quantity: 12,534 cartons, 125,340 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- January 16, 2019
- Initiation Date
- January 3, 2019
- Termination Date
- November 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,534 cartons, 125,340 vials
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019