Drug product
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
D-0798-2021
Product summary
- Firm
- Viatris
- Event
- Event 88609
- Status
- Terminated
- Classification
- Class III
- Quantity
- 21,094
- Official record key
drug-enforcement:D-0798-2021
Official wording
Reason: Failed Impurities/Degradation Specifications; out of specification for Related Compound
Code information: Lot # 3107334, exp. date October 2021
Distribution pattern: Product was distributed nationwide.
Derived failure modes
-
Potency or specification failure
out of specification