Recalls / Class I
Class ID-0372-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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]
- Brand name
- Vecuronium Bromide
- Generic name
- Vecuronium Bromide
- Active ingredient
- Vecuronium Bromide
- Route
- Intravenous
- NDCs
- 47335-931, 47335-932
- FDA application
- ANDA079001
- Affected lot / code info
- Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
Why it was recalled
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
Recalling firm
- Firm
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 12,534 cartons, 125,340 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-01-03
- FDA classified
- 2019-01-14
- Posted by FDA
- 2019-01-16
- Terminated
- 2021-11-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0372-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.