Drug product

Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.

D-0267-2024

January 18, 2024

Class II

Product summary

Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Code information: Lot #s: DNE0621A Exp. 11/30/2024, DNE0815A Exp. 12/31/2024

Distribution pattern: Nationwide in the USA

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

Microbial contamination