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.
Reported: June 20, 2012 Initiated: May 1, 2012 #D-1376-2012
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.
Details
- Recalling Firm
- Ben Venue Laboratories Inc
- Units Affected
- 11,161 packs
- Distribution
- Nationwide and Puerto Rico.
- Location
- Bedford, OH
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ben Venue Laboratories Inc. Units affected: 11,161 packs.
Why was this product recalled? ▼
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 20, 2012. Severity: Moderate. Recall number: D-1376-2012.
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