Recall Enforment Report D-0266-2024

Multi event Drug Recall Enforcement Report Class II voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 01-18-2024 for the product 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. The product was recalled due to cgmp deviations: microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0266-202401-18-202401-31-2024Class II11,400 bottlesLurasidone 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.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0263-202401-18-202401-31-2024Class II1,728 bottlesCinacalcet 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.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0271-202401-18-202401-31-2024Class II1220 bottlesZolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 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 47335-307-88.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0273-202401-18-202401-31-2024Class II54,504 bottlesFexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0264-202401-18-202401-31-2024Class II55,272 bottlesFebuxostat Tablets 40mg, 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 47335-721-83.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0270-202401-18-202401-31-2024Class II15,768 bottlesNiacin Extended-Release Tablets, USP 500mg, Rx Only, 90 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 47335-539-81.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0272-202401-18-202401-31-2024Class II14,568 bottlesZolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 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 47335-308-88.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0265-202401-18-202401-31-2024Class II19,992 bottlesFebuxostat Tablets 80 mg, 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 47335-722-83.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0267-202401-18-202401-31-2024Class II9,408 bottlesLurasidone 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.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0268-202401-18-202401-31-2024Class II10,690 bottlesMesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, 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 63304-175-13.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing
D-0269-202401-18-202401-31-2024Class II6552 bottlesNiacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 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 47335-613-81.CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
47335-307Zolpidem Tartrate Zolpidem TartrateTablet, Film Coated, Extended ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-308Zolpidem Tartrate Zolpidem TartrateTablet, Film Coated, Extended ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-379Cinacalcet CinacalcetTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-380Cinacalcet CinacalcetTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-539Niacin NiacinTablet, Film Coated, Extended ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-578Lurasidone Hydrochloride Lurasidone HydrochlorideTabletOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-579Lurasidone Hydrochloride Lurasidone HydrochlorideTabletOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-600Cinacalcet CinacalcetTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-613Niacin NiacinTablet, Film Coated, Extended ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-614Niacin NiacinTablet, Film Coated, Extended ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-639Lurasidone Hydrochloride Lurasidone HydrochlorideTabletOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-684Lurasidone Hydrochloride Lurasidone HydrochlorideTabletOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-685Lurasidone Hydrochloride Lurasidone HydrochlorideTabletOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-721Febuxostat FebuxostatTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
47335-722Febuxostat FebuxostatTablet, Film CoatedOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
51316-800Fexofenadine Hydrochloride Fexofenadine HydrochlorideTabletOralCvs Pharmacy, IncHuman Otc Drug
51660-998Fexofenadine Hydrochloride Fexofenadine HydrochlorideTablet, Film CoatedOralOhm Laboratories Inc.Human Otc Drug
63304-175Mesalamine MesalamineTablet, Delayed ReleaseOralSun Pharmaceutical Industries, Inc.Human Prescription Drug