Recalls / Class II
Class IID-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.
- Affected lot / code info
- Lot #1856177, Exp 06/30/13
Why it was recalled
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Recalling firm
- Firm
- Ben Venue Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 300 Northfield Rd, Bedford, Ohio 44146
Distribution
- Quantity
- 11,161 packs
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2012-05-01
- FDA classified
- 2012-06-14
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1376-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.