Vecuronium Bromide for Injection recall: Sterility Concern
Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
Why was Vecuronium Bromide for Injection recalled?
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
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 # 31325712B, exp. date 12/2021 31326320B, exp. date 02/2022 31326457B, exp. date 02/2022 31327880B, exp. date 10/2022
- Product
- Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 33,6697 vials
- Distribution
- Product was distributed nationwide in the USA and Puerto Rico.
- Recall date
- March 3, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)