Drug recall
Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL Lyophilized, 10 x 10 mg vials, Rx…
FDA recall event 81891 · Class I · Sun Pharmaceutical Industries, Inc.
Key facts
| Event ID | 81891 |
|---|---|
| Recall numbers | D-0372-2019, D-0373-2019 |
| Recalling firm | Sun Pharmaceutical Industries, Inc. |
| Product type | Drugs |
| Products | 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…, Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized, 10 x 20 mg vials, Rx Only, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway Halol-389… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection. |
| Initiation date | Jan 3, 2019 |
| Report date | Jan 16, 2019 |
| Termination date | Nov 3, 2021 |
| City | Cranbury |
| State | NJ |
| Country | United States |
| FEI number | 3005551493 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: