FDA-Drug2021-09-22Class III

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Viatris
Hazard

Failed Impurities/Degradation Specifications; out of specification for Related Compound

Sold states
Product was distributed nationwide.
Affected count
21,094
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2021

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