Reported Feb 19, 2014 · Terminated
Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd.,…
Caraco Pharmaceutical Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Caraco Pharmaceutical Laboratories Ltd. · 270 Prospect Plains Rd · Cranbury, NJ · 08512-3605
Is this the product you have?
- Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only
- Distributed byCaraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202
- Manufactured bySun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets
- PharmacistDispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP
- Usual DosageSee package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI
- Lot codes and dates
- Lot #: JKM7075A
- Expiry10/15
- Amount recalled
- 7005 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Tablet Specifications: Broken Tablets Present.
This product could cause temporary or reversible health problems — stop using it.
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