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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

Product Description Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Recall Number D-193-2013
Classification Class II
Code Info Lot # N03029, Exp 03/14
Product Distributed Qty 3,913 bottles
Reason For Recall Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.

Event Detail

Event Id 64233
Product Type Drugs
Status Ongoing
Recalling Firm Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide