Carbidopa And Levodopa Tablet
FDA Recall NDC 62756-985
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Carbidopa And Levodopa (NDC 62756-985). A significant event, classified as Class II, was initiated on Jan 12, 2017 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Dissolution Specifications"
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
Failed Dissolution Specifications
Jan 12, 2017
Feb 08, 2017
8,537 bottles
Recall Profile & Regulatory Data
Event ID
76230
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sun Pharmaceutical Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 29, 2018
Product Description
Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottles (NDC 62756-519-88), b) 500-count bottles (NDC 62756-519-13) Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat, India.
Batch or Lot Expiration Information
Lot# a) JKP5530A Exp. 12/17, JKP3991A Exp. 11/17, JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17
Affected Packages Involved in this Recall
62756-517-83Product
62756-517-88Product
62756-517-08Product
62756-517-13Product
62756-517-18Product
62756-518-83Product
62756-518-88Product
62756-518-08Product
62756-518-13Product
62756-518-18Product
62756-519-83Product
62756-519-88Product
62756-519-08Product
62756-519-13Product
62756-519-18Product
62756-985-01Product
62756-985-02Product
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.
