Recall: D-0798-2021

Class III - Minor Violations

Class IIIClassification

2021-09-13Initiated

TerminatedStatus

ViatrisFirm

Product

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

Reason

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

Distribution

Product was distributed nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.