Drug 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....
D-1081-2014
Product summary
- Event
- Event 67426
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7005 bottles
- Official record key
drug-enforcement:D-1081-2014
Official wording
Reason: Failed Tablet Specifications: Broken Tablets Present.
Code information: Lot #: JKM7075A, Expiry:10/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Tablet Specifications: Broken Tablets Present.