Enforcement Report - Week of June 20, 2012
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Product Detail
| Product Description | Octreotide Acetate Injection, 50 mcg/mL (0.05 mg/mL), 1 mL single dose vials, packaged in 10 x 1 mL single dose vials per pack, Rx only, Manufactured for: Bedford Laboratories, Bedford, OH 44146; Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; NDC 55390-160-10; UPC 3 55390-160-10 1. |
|---|---|
| Recall Number | D-1377-2012 |
| Classification | Class II |
| Code Info | Lot # 2006500, Exp 08/31/12 |
| Product Distributed Qty | 6,515 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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