FDAFDA · Food and drugs·Recall number D-0049-2021
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.
Published October 28, 2020 · Recall initiated: October 2, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out-of-specification organic impurity results obtained during routine stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0303783003771
- Lot
- Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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