drugs Class II Updated 2014-02-19

Caraco Pharmaceutical Laboratories Ltd. recalls Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only.

Recalled 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....

Hazard / Issue

Failed Tablet Specifications: Broken Tablets Present.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: JKM7075A, Expiry:10/15
View official government recall

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