Midazolam HCl Injection — Class II drug recall D-1376-2012
Terminated recall by Ben Venue Laboratories Inc, reported 2012-06-20, distributed nationwide. Short Fill: These products are being recalled because there is potential that vials with low fill volume were
| Recall number | D-1376-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ben Venue Laboratories Inc, Bedford, OH, United States |
| Recall initiated | 2012-05-01 |
| Classified | 2012-06-14 |
| Reported by FDA | 2012-06-20 |
| Terminated | 2013-08-21 |
| Distributed | Nationwide (US) |
| Quantity | 11,161 packages |
| NDC | 55390-0138-01 |
| Lot numbers | 1856177 |
| Expiration dates | 2013-06-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1376-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.