Drug recall D-0455-2017

Class II Terminated reported Feb 8, 2017

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.

Reason for recall

Failed Dissolution Specifications

Lots and codes

a) JKP5530A Exp. 12/17, JKP3991A Exp. 11/17, JKR6535A Exp. 07/18 b) JKP5529A Exp. 11/17

Recall details

Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ
Quantity
8,537 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 12, 2017
Terminated
June 29, 2018

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