Drug recall D-0798-2021
Product
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
Lots and codes
Lot # 3107334, exp. date October 2021
Recall details
- Recalling firm
- Viatris, Morgantown, WV
- Quantity
- 21,094
- Distribution
- Product was distributed nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 13, 2021
- Terminated
- April 28, 2022
Related products
- Candesartan cilexetil – drug information
- NDC 0378-3231 Candesartan cilexetil · Candesartan Cilexetil 16 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3232 Candesartan cilexetil · Candesartan Cilexetil 32 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3224 Candesartan cilexetil · Candesartan Cilexetil 4 mg/1 · Mylan Pharmaceuticals Inc.
- NDC 0378-3225 Candesartan cilexetil · Candesartan Cilexetil 8 mg/1 · Mylan Pharmaceuticals Inc.