Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

FDA recall notice · announced September 22, 2021 · Viatris

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Product was distributed nationwide.
Lot/code information: Lot # 3107334, exp. date October 2021
Quantity: 21,094
Status: Terminated
Products in this recall event:
- Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 (D-0798-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.