FDA-Drug2017-02-08Class II

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.

Sun Pharmaceutical Industries, Inc.
Hazard

Failed Dissolution Specifications

Sold states
Nationwide
Affected count
8,537 bottles
Manufactured in
270 Prospect Plains Rd, N/A, Cranbury, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0455-2017

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