Recalls / Class II
Class IID-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....
- Brand name
- Oxcarbazepine
- Generic name
- Oxcarbazepine
- Active ingredient
- Oxcarbazepine
- Route
- Oral
- NDCs
- 62756-183, 62756-184, 62756-185
- FDA application
- ANDA077794
- Affected lot / code info
- Lot #: JKM7075A, Expiry:10/15
Why it was recalled
Failed Tablet Specifications: Broken Tablets Present.
Recalling firm
- Firm
- Caraco Pharmaceutical Laboratories Ltd.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 270 Prospect Plains Rd, N/A, Cranbury, New Jersey 08512-3605
Distribution
- Quantity
- 7005 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-01-29
- FDA classified
- 2014-02-10
- Posted by FDA
- 2014-02-19
- Terminated
- 2014-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1081-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.