# FDA recall D-1376-2012

> **Ben Venue Laboratories Inc** · Class II · drug recall initiated 2012-05-01.

## 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

- **Recall number:** D-1376-2012
- **Recalling firm:** Ben Venue Laboratories Inc
- **Classification:** Class II
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1376-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1376-2012. Source: US FDA. Licensed CC0.

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