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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Detail

Product Description Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Recall Number D-393-2014
Classification Class II
Code Info Lot CU0856
Product Distributed Qty 2,491 bottles of 100 tablets each
Reason For Recall Subpotent; Hydrochlorothiazide at the 9 month time point.

Event Detail

Event Id 66554
Product Type Drugs
Status Ongoing
Recalling Firm Sandoz Inc
City Wilson
State NC
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-10-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide
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