FDA recall D-1376-2012

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.

Reason for recall

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

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-05-01

Report date

2012-06-20

Termination date

2013-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedford, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1376-2012