Drug 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.
D-0049-2021
Product summary
- Event
- Event 86520
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,695 bottles
- Official record key
drug-enforcement:D-0049-2021
Official wording
Reason: Out-of-specification organic impurity results obtained during routine stability testing.
Code information: Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Out-of-specification