Enforcement Report - Week of January 30, 2013
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Product Detail
| Product Description | Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724. |
|---|---|
| Recall Number | D-130-2013 |
| Classification | Class II |
| Code Info | Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16 |
| Product Distributed Qty | 32,550 bottles |
| Reason For Recall | Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubicant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets. |
Event Detail
| Event Id | 63871 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | West-ward Pharmaceutical Corp. |
| City | Eatontown |
| State | NJ | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico |
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