D-0798-2021 Class III Terminated
FDA drug recall D-0798-2021 was initiated by Viatris on September 13, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications; out of specification for Related Compound The recall status is terminated (terminated April 28, 2022). Affected quantity: 21,094.
Recall Details
- Product Type
- Drugs
- Report Date
- September 22, 2021
- Initiation Date
- September 13, 2021
- Termination Date
- April 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,094
Product Description
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Reason for Recall
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Distribution Pattern
Product was distributed nationwide.
Code Information
Lot # 3107334, exp. date October 2021