Class III
Terminated
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.
This recall has been terminated (originally issued October 28, 2020).
- Company
- Mylan Pharmaceuticals Inc.
- Recall Initiated
- October 2, 2020
- Posted
- October 28, 2020
- Recall Number
- D-0049-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10,695 bottles
- Firm Location
- Morgantown, WV, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Out-of-specification organic impurity results obtained during routine stability testing.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
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