PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: February 8, 2017 Initiated: January 12, 2017 #D-0455-2017

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.

Reason for Recall

Failed Dissolution Specifications

Details

Units Affected
8,537 bottles
Distribution
Nationwide
Location
Cranbury, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Sun Pharmaceutical Industries, Inc.. Units affected: 8,537 bottles.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on February 8, 2017. Severity: Moderate. Recall number: D-0455-2017.