Drug product
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.
D-1376-2012
Product summary
- Event
- Event 61802
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,161 packs
- Official record key
drug-enforcement:D-1376-2012
Official wording
Reason: 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
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.