Drug recall D-1081-2014
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....
Reason for recall
Failed Tablet Specifications: Broken Tablets Present.
Lots and codes
Lot #: JKM7075A, Expiry:10/15
Recall details
- Recalling firm
- Caraco Pharmaceutical Laboratories Ltd., Cranbury, NJ
- Quantity
- 7005 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 29, 2014
- Terminated
- September 29, 2014
Related products
- Oxcarbazepine – drug information
- NDC 62756-184 Oxcarbazepine · Oxcarbazepine 300 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-183 Oxcarbazepine · Oxcarbazepine 150 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 62756-185 Oxcarbazepine · Oxcarbazepine 600 mg/1 · Sun Pharmaceutical Industries, Inc.