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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description Belladonna Alkaloids (hyoscyamine sulfate, USP 0.1037 mg; atropine sulfate, USP 0.0194 mg; scopolamine HBr, USP 0.0065 mg) with Phenobarbital (USP 16.2 mg) Tablets, packaged in a) 1000-count tablets per bottle (NDC 0143-1140-10; b) 5000-count tablets per bottle (NDC 143-1140-51); Rx only, Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724
Recall Number D-170-2013
Classification Class II
Code Info Lot #: 69099A, 69099B, Exp 08/15
Product Distributed Qty 6,511 bottles
Reason For Recall Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Event Detail

Event Id 64107
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 2013-01-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide