February 2020 FDA Recall Drug by Aaa Pharmaceutical, Inc.
D-0868-2020 - Labeling

This Class III drug recall was voluntarily initiated by Aaa Pharmaceutical, Inc. on February 14, 2020 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Ohio and the recall is currently terminated.

Recall Number: D-0868-2020

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Expiration date.
Initiated
02-14-2020
Reported
03-11-2020
Quantity
3456 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84938
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.
AAA Pharmaceutical, 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.
Ohio
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-05-2023
Product Description About Product Description
Full technical description of the product.
Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, 24 Hour, a) 30 tablets per bottle, NDC 53943-192-04, UPC Code 0-93351-03069-7; b) 45 tablets per bottle, NDC 53943-192-06, UPC Code 0-93351-03070-3, Distributed by: Drug Mart -Food Fair, 211 Commerce Drive, Medina, OH 44256.

Batch or Lot Expiration Information

Lot# s: a) P138855, Exp. 05/30/2022; b) P138856, Exp. 05/30/2022