January 2017 FDA Recall Carbidopa And Levodopa by Sun Pharmaceutical Industries, Inc.
D-0455-2017 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries, Inc. on January 12, 2017 for the product Carbidopa And Levodopa. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0455-2017
Failed Dissolution Specifications
01-12-2017
02-08-2017
8,537 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.
Sun Pharmaceutical Industries, Inc.
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
06-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
