Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
Reason
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Classification
Class II
Status
Completed
Lot
Lot #: DNE0702A, Exp. 06/30/2026
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.