Product: Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Reason for recall: Out-of-specification organic impurity results obtained during routine stability testing.
Recall initiated: 20201002
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated