FDA-Drug2024-01-31Class II
Lurasidone Hydrochloride Tablets 60mg, 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 47335-639-83.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sold states
Nationwide in the USA
Affected count
11,400 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
Lurasidone Hydrochloride Tablets 60mg, 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 47335-639-83.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0266-2024Don't want to check this manually?
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