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FDAOctober 2, 2020drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

mylan pharmaceuticalsmylan

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. — Recall Details · AllClear