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U.S. Department of Health and Human Services

Enforcement Report - Week of August 7, 2013

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Product Detail

Product Description Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-count bottle (NDC 54868-0031-04), Rx only, Repackaged and distributed by Physicians Total Care, Inc. Tulsa, OK 74146.
Recall Number D-826-2013
Classification Class II
Code Info Lot# 6GP2; Exp 10/14 West-Ward Lot /WWCN 67331A
Product Distributed Qty 270 tablets
Reason For Recall Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Event Detail

Event Id 65601
Product Type Drugs
Status Completed
Recalling Firm Physicians Total Care, Inc.
City Tulsa
State OK
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-17
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern GA