FDAFDA · Food and drugs·Recall number D-1081-2014
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....
Published February 19, 2014 · Recall initiated: January 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Tablet Specifications: Broken Tablets Present.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Brand
- OXCARBAZEPINE
- Manufacturer
- Caraco Pharmaceutical Laboratories Ltd.
- Distributor
- Nationwide
- UPC
- 0362756183834
- Lot
- Lot #: JKM7075A, Expiry:10/15
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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