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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Product Detail

Product Description West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Recall Number D-824-2013
Classification Class II
Code Info Lot # 69098A, 69098B, 69100A; Exp 8/15
Product Distributed Qty 14,503 bottles
Reason For Recall Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Event Detail

Event Id 65445
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 2013-05-16
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide