Why it was recalled
Failed Tablet Specifications: Broken Tablets Present.
Product description
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....
Lot numbers, UPCs & expiration codes
Lot #: JKM7075A, Expiry:10/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1081-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 29, 2014
- FDA report date
- Feb 19, 2014
- Quantity
- 7005 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Caraco Pharmaceutical Laboratories Ltd.
Original FDA data
Every field from FDA enforcement report D-1081-2014, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67426
- Address
- 270 Prospect Plains Rd
- Code information
- Lot #: JKM7075A, Expiry:10/15
- Postal code
- 08512-3605
- Report date
- Feb 19, 2014
- Product type
- Drugs
- Recall number
- D-1081-2014
- Classification
- Class II
- Recalling firm
- Caraco Pharmaceutical Laboratories Ltd.
- Product quantity
- 7005 bottles
- Termination date
- Sep 29, 2014
- Reason for recall
- Failed Tablet Specifications: Broken Tablets Present.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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....
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 29, 2014
- Initial firm notification
- Center classification date
- Feb 10, 2014