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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 29, 2014 · Data as of Sep 19, 7:52 PM UTC

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