Mylan LLC.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

mylan, mylan pharmaceuticals, mylan special product line

Recent Recalls

NumberClassProductDate
D-0441-2017Class IITemozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottleDecember 20, 2016
D-0444-2017Class IITemozolomide Capsules, 250 mg, 5-count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WVDecember 20, 2016
D-0443-2017Class IITemozolomide Capsules, 180 mg, packaged in a) 5-count bottles (NDC 0378-5264-98), b) 14-count bottleDecember 20, 2016
D-0442-2017Class IITemozolomide Capsules, 140 mg, packaged in a) 5-count bottles (NDC 0378-5263-98), b) 14-count bottleDecember 20, 2016
D-066-2013Class IIMylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., MorgantownJune 29, 2012