PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 22, 2021 Initiated: September 13, 2021 #D-0798-2021

Product Description

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

Reason for Recall

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

Details

Recalling Firm
Viatris
Units Affected
21,094
Distribution
Product was distributed nationwide.
Location
Morgantown, WV

Frequently Asked Questions

What product was recalled?
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93. Recalled by Viatris. Units affected: 21,094.
Why was this product recalled?
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Which agency issued this recall?
This recall was issued by the FDA Drug on September 22, 2021. Severity: Low. Recall number: D-0798-2021.