FDA Drug recall D-0372-2019
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun P…
- FDA Drug
- Class I
- terminated
- Published 2019-01-16
On 2019-01-16 the FDA classified a Class I recall of Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx only, Manufactured by: Sun P… by Sun Pharmaceutical Industries, citing presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0372-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-01-03 |
| Published | 2019-01-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
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
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Identifiers
| ndc | 47335-931-40 |
|---|---|
| ndc | 47335-931-44 |
| ndc | 47335-932-40 |
| ndc | 47335-932-44 |
| code_info | Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0372-2019%22
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