Oxcarbazepine Tablet, Film Coated
FDA Recall NDC 62756-183
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Oxcarbazepine (NDC 62756-183). A significant event, classified as Class II, was initiated on Dec 01, 2022 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Presence of foreign substance"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of foreign substance
Dec 01, 2022
Dec 28, 2022
Lot HAC1474A: 4296 Bottles, Lot HAC1474B: 145 Bottles, Lot HAC1503A: 2124 Bottles
Recall Profile & Regulatory Data
Event ID
91311
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 13, 2023
Product Description
Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Batch or Lot Expiration Information
Lot# a) Lot HAC1474A, Expires 03/2023 b) Lot HAC1503A, Expires 03/2023 c) Lot HAC1474B, Expires 03/2023
Affected Packages Involved in this Recall
62756-183-83Product
62756-183-88Product
62756-183-08Product
62756-183-13Product
62756-183-18Product
62756-184-83Product
62756-184-88Product
62756-184-08Product
62756-184-13Product
62756-184-18Product
62756-185-83Product
62756-185-88Product
62756-185-08Product
62756-185-13Product
62756-185-18Product
Class II Terminated
Failed Tablet Specifications: Broken Tablets Present.
Jan 29, 2014
Feb 19, 2014
7005 bottles
Recall Profile & Regulatory Data
Event ID
67426
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Caraco Pharmaceutical Laboratories Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 29, 2014
Product Description
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
Affected Packages Involved in this Recall
62756-183-83Product
62756-183-88Product
62756-183-08Product
62756-183-13Product
62756-183-18Product
62756-184-83Product
62756-184-88Product
62756-184-08Product
62756-184-13Product
62756-184-18Product
62756-185-83Product
62756-185-88Product
62756-185-08Product
62756-185-13Product
62756-185-18Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
