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....

This recall has been terminated (originally issued February 19, 2014).

Company

Caraco Pharmaceutical Laboratories Ltd.

Recall Initiated

January 29, 2014

Posted

February 19, 2014

Recall Number

D-1081-2014

Voluntary / Mandated

Voluntary: Firm initiated

Quantity

7005 bottles

Firm Location

Cranbury, NJ, United States

Official Source

View on FDA website ↗