October 2020 FDA Recall Candesartan Cilexetil And Hydrochlorothiazide by Mylan Pharmaceuticals Inc.
D-0049-2021 - Out-of-specification organic impurity results obtained during routine stability testing.

This Class III drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on October 2, 2020 for the product Candesartan Cilexetil And Hydrochlorothiazide. The FDA reported the reason for recall as out-of-specification organic impurity results obtained during routine stability testing.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0049-2021

Reason for Recall
Out-of-specification organic impurity results obtained during routine stability testing.
Initiated
10-02-2020
Reported
10-28-2020
Quantity
10,695 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
86520
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-24-2022
Product Description About Product Description
Full technical description of the product.
Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Batch or Lot Expiration Information

Lot# : a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021

Affected Packages Involved in this Recall

0378-3001-77 Candesartan Cilexetil And Hydrochlorothiazide
0378-3002-77 Candesartan Cilexetil And Hydrochlorothiazide
0378-3003-77 Candesartan Cilexetil And Hydrochlorothiazide
0378-3002-05 Candesartan Cilexetil And Hydrochlorothiazide