September 2021 FDA Recall Candesartan Cilexetil by Viatris
D-0798-2021 - Failed Impurities/Degradation Specifications; out of specification for Related Compound
This Class III drug recall was voluntarily initiated by Viatris on September 13, 2021 for the product Candesartan Cilexetil. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification for related compound. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0798-2021
Failed Impurities/Degradation Specifications; out of specification for Related Compound
09-13-2021
09-22-2021
21,094
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Viatris
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed nationwide.
04-28-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Batch or Lot Expiration Information
Lot# 3107334, exp. date October 2021
