FDAFDA · Food and drugs·Recall number D-1376-2012
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.
Published June 20, 2012 · Recall initiated: May 1, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ben Venue Laboratories Inc
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #1856177, Exp 06/30/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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