PlainRecordsFDA · Drug recall
Vecuronium Bromide for Injection 10 mg*… and 1 more product
- Date
- Jan. 16, 2019
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)
- Status
- Terminated
- Filed by
- Sun Pharmaceutical Industries, Inc.
- Reason
- Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
- Distribution pattern
- Nationwide in the USA
2 products in this recall
Vecuronium Bromide for Injection 10 mg*…
- 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]
- Quantity
- 12,534 cartons, 125,340 vials
- Codes and lots
- Lot #: JKS0443A, JKS0444A, JKS0477A, EXP 03/2019
- Recall started
- Jan. 3, 2019
- Recall number
- D-0372-2019
Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL Lyophilized…
- Product
- 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-389 350, Gujarat, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC: 47335-932-40 [vial] 47335-932-44 [carton]
- Quantity
- 1,384 cartons, 13,840 vials
- Codes and lots
- Lot #: JKS0400A, EXP 03/2019
- Recall started
- Jan. 3, 2019
- Recall number
- D-0373-2019
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement reports, recall numbers D-0372-2019, D-0373-2019. The agency record governs; check it and the company before acting.