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U.S. Department of Health and Human Services

Enforcement Report - Week of February 19, 2014

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Product Detail

Product Description Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI....
Recall Number D-1081-2014
Classification Class II
Code Info Lot #: JKM7075A, Expiry:10/15
Product Distributed Qty 7005 bottles
Reason For Recall Failed Tablet Specifications: Broken Tablets Present.

Event Detail

Event Id 67426
Product Type Drugs
Status Ongoing
Recalling Firm Caraco Pharmaceutical Laboratories Ltd.
City Cranbury
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-29
Initial Firm Notification of Consignee or Public E-Mail
Distribution Pattern Nationwide
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