August 2019 FDA Recall Drug by Avkare Inc.
D-1875-2019 - Failed Stability Specifications.

This Class II drug recall was voluntarily initiated by Avkare Inc. on August 28, 2019 for the product Drug. The FDA reported the reason for recall as failed stability specifications.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1875-2019

Reason for Recall
Failed Stability Specifications.
Initiated
08-28-2019
Reported
09-18-2019
Quantity
5953 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83700
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AVKARE 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 in the U.S.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the product.
AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

Batch or Lot Expiration Information

Lot# s: 067180011A; 067180012A, Exp. 04/2021; 06718027B1 Exp. 09/2021