Recall Enforment Report D-0798-2021

Drug Recall Enforcement Report Class III voluntary initiated by Viatris, originally initiated on 09-13-2021 for the product Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93 The product was recalled due to failed impurities/degradation specifications; out of specification for related compound. The product was distributed nationwide and the recall is currently ongoing.

Field Name Field Value
Event ID 88609 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0798-2021 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Product was distributed nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 21,094 Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 09-22-2021
Recall Initiation Date 09-13-2021 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Viatris
Code Info Lot # 3107334, exp. date October 2021 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0378-3224-93; 0378-3224-77; 0378-3225-93; 0378-3225-77; 0378-3231-93; 0378-3231-77; 0378-3232-93; 0378-3232-77
Status Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0378-3224Candesartan Cilexetil Candesartan CilexetilTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-3225Candesartan Cilexetil Candesartan CilexetilTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-3231Candesartan Cilexetil Candesartan CilexetilTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-3232Candesartan Cilexetil Candesartan CilexetilTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug