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U.S. Department of Health and Human Services

Enforcement Report - Week of January 30, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. 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 Class II 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. 32,550 bottles D-130-2013
Propylthiouracil Tablets, USP, 50 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1480-01) and b) 1000-count tablets per bottle (NDC 0143-1480-10), Rx only, Manufactured by: West-ward Pharmaceuticals Corp. Eatontown, NJ 07724. Lot #: 68478A, 69059A, 69059B, Exp 01/16 Class II Presence of Foreign Substance: Uncharacteristic spots identified as steel corrosion, degraded tablet material and hydrocarbon oil with trace amounts of iron were found in tablets. 43,075 bottles D-131-2013
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