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U.S. Department of Health and Human Services

Enforcement Report - Week of October 16, 2013

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Product Detail

Product Description Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.
Recall Number D-66360-001
Classification Class II
Code Info Lot#: 580974AA and 580975AA. Exp: 09/14
Product Distributed Qty 1,002,394 tablets
Reason For Recall Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Event Detail

Event Id 66360
Product Type Drugs
Status Ongoing
Recalling Firm Watson Laboratories Inc
City Corona
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-23
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US. No international. NATIONWIDE