Vecuronium Bromide for Injection 20 mg* *1mg/mL when recall: Particulate Matter
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]
Why was Vecuronium Bromide for Injection 20 mg* *1mg/mL when recalled?
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: JKS0400A, EXP 03/2019
- 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]
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Quantity
- 1,384 cartons, 13,840 vials
- Distribution
- Nationwide in the USA
- Recall date
- January 16, 2019
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (drug)