Northwind Pharmaceuticals LLC

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
0
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0654-2025Class IISulfamethoxazole and Trimethoprim Tablets, USP 800mg / 160mg Double Strength packaged in a) 6-count August 20, 2025
D-0549-2023Class IIBusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind PhaMarch 16, 2023
D-0553-2023Class IITadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count botMarch 16, 2023
D-0552-2023Class IIGlimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count boMarch 16, 2023
D-0548-2023Class IIAtorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind PharmaMarch 16, 2023
D-0550-2023Class IIDoxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, InMarch 16, 2023
D-0551-2023Class IIGlimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count botMarch 16, 2023
D-0554-2023Class IITadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, InMarch 16, 2023
D-1097-2018Class IIValsartan, 80mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, IndianapoJuly 18, 2018
D-1095-2018Class IIValsartan, 160 mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, IndianaJuly 18, 2018
D-1096-2018Class IIValsartan HCTZ, 160/12.5mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind PharmaceuticalsJuly 18, 2018
D-1098-2018Class IIValsartan, 320mg, 30 tablets per bottle, Rx Only, Repackaged By: Northwind Pharmaceuticals, IndianapJuly 18, 2018
D-0485-2016Class IIIPrednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 AmmaNovember 10, 2015