Recall: D-0049-2021

Class III - Minor Violations

Class IIIClassification

2020-10-02Initiated

TerminatedStatus

Mylan Pharmaceuticals Inc.Firm

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

Out-of-specification organic impurity results obtained during routine stability testing.

Distribution

Nationwide within the United States

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