Enforcement Report - Week of June 20, 2012
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Product Detail
| 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. |
|---|---|
| Recall Number | D-1376-2012 |
| Classification | Class II |
| Code Info | Lot #1856177, Exp 06/30/13 |
| Product Distributed Qty | 11,161 packs |
| Reason For Recall | Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution. |
Event Detail
| Event Id | 61802 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Ben Venue Laboratories Inc |
| City | Bedford |
| State | OH | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico. |
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