Mylan Laboratories Limited, (Nashik FDF)

FDA Regulatory Profile

Mylan Laboratories Limited, (Nashik FDF) appears in FDA public data with 13 recalls, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (D-0326-2019, Class II) was initiated on December 4, 2018.

Summary

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

Recent Recalls

NumberClassProductDate
D-0326-2019Class IIValsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan PhaDecember 4, 2018
D-0329-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), December 4, 2018
D-0331-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), December 4, 2018
D-0332-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (bDecember 4, 2018
D-0328-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (December 4, 2018
D-0330-2019Class IIValsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (bDecember 4, 2018
D-0327-2019Class IIValsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan PhaDecember 4, 2018
D-0321-2019Class IIAmlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, ManufactuDecember 4, 2018
D-0322-2019Class IIAmlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, ManufacturDecember 4, 2018
D-0324-2019Class IIValsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan PharDecember 4, 2018
D-0320-2019Class IIAmlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, ManufactuDecember 4, 2018
D-0323-2019Class IIAmlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, ManufactuDecember 4, 2018
D-0325-2019Class IIValsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan PharDecember 4, 2018