FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per...

  • U.S. Food and Drug Administration
  • June 20, 2012
  • ID: D-1376-2012

Drug Enforcement Report Details

Recall NumberD-1376-2012
Recalling FirmBen Venue Laboratories Inc
ClassificationClass II
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternNationwide and Puerto Rico.
StatusTerminated
Product Description

Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01 8.

Reason for Recall

Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Code Information

Lot #1856177, Exp 06/30/13


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.