January 2014 FDA Recall Oxcarbazepine by Caraco Pharmaceutical Laboratories Ltd.
D-1081-2014 - Failed Tablet Specifications
This Class II drug recall was voluntarily initiated by Caraco Pharmaceutical Laboratories Ltd. on January 29, 2014 for the product Oxcarbazepine. The FDA reported the reason for recall as failed tablet specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1081-2014
Failed Tablet Specifications: Broken Tablets Present.
01-29-2014
02-19-2014
7005 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Caraco Pharmaceutical Laboratories Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
09-29-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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....
Batch or Lot Expiration Information
Lot# : JKM7075A, Expiry:10/15
