Enforcement Report - Week of November 7, 2012
-
Back to Previous Page
Product Detail
| Product Description | Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus) |
|---|---|
| Recall Number | D-036-2013 |
| Classification | Class II |
| Code Info | Lot #, 2017619 (Bedford), Mfr Item # 0967-57-2017619, NDC, 55390-009-01, Exp. Date 11/2012; Lot# 2017620, Exp. Date 1/2013, NDC #55390-009-01; Lot #, 2017621 (Bedford), Mfr Item # 0967-57-2017621, NDC, 55390-009-01, Exp Date 01/2013; Lot #2038374, exp. 2/2013, NDC #55390-009-01; Lot #2038374A, exp. 2/2013, NDC #55390-826-01 Note: 2038374A (packaged using Novaplus labeling) is a sublot of 2038374 (packaged using Bedford labeling); Lot #, 2038375 (Bedford), Mfr Item # 0967-57-2038375, NDC, 55390-009-01, Exp Date 03/2013; Lot #, 2065418 (Bedford), Mfr Item # 0967-57-2065418, NDC, 55390-009-01, Exp Date 06/2013; Lot #, 2067176 (Bedford), Mfr Item # 0967-57-2067176, NDC, 55390-009-01, Exp Date, 06/2013; Lot #, 2067177 (Bedford), Mfr Item # 0967-57-2067177, NDC, 55390-009-01, Exp Date 06/2013 & Lot #, 2067178A (Novaplus), Mfr Item # 0967-57-2067178A, NDC, 55390-826-01, Exp Date, 06/2013. |
| Product Distributed Qty | 226,010 vials |
| Reason For Recall | Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample |
Event Detail
| Event Id | 62490 |
|---|---|
| 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 | 2012-07-05 |
| Initial Firm Notification of Consignee or Public | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Distribution Pattern | Nationwide and Puerto Rico. |
-
