FDA-Drug2020-10-28Class III
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.
Mylan Pharmaceuticals Inc.
Hazard
Out-of-specification organic impurity results obtained during routine stability testing.
Sold states
Nationwide within the United States
Affected count
10,695 bottles
Manufactured in
781 Chestnut Ridge Rd, N/A, Morgantown, WV, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2021Don't want to check this manually?
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