Caraco Pharmaceutical Laboratories Ltd. recalls Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1
Recalled February 19, 2014 · FDA recall D-1081-2014 · Caraco Pharmaceutical Laboratories
Hazard
Failed Tablet Specifications: Broken Tablets Present. · FDA Class II
Units
7005 bottles
Sold at
Nationwide
Description
Failed Tablet Specifications: Broken Tablets Present.
Product
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....
Manufacturer(s)
Caraco Pharmaceutical Laboratories Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →