June 2019 FDA Recall Drug by Aaa Pharmaceutical, Inc.
D-1585-2019 - Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.

This Class III drug recall was voluntarily initiated by Aaa Pharmaceutical, Inc. on June 25, 2019 for the product Drug. The FDA reported the reason for recall as labeling; incorrect or missing lot number and/or exp date; product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.. The product was distributed in KS and the recall is currently terminated.

Recall Number: D-1585-2019

Reason for Recall
Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Initiated
06-25-2019
Reported
08-14-2019
Quantity
a) 288 bottles b) 48 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83210
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.
KS
Termination Date About Termination Date
Date that FDA officially terminated the recall.
12-16-2020
Product Description About Product Description
Full technical description of the product.
Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83967-38786-1 bottles, Distributed by: Kmart Corporation Hoffman Estates, IL 60179

Batch or Lot Expiration Information

Lot# a) P136370, exp 9/2022 b) P136366, exp 9/2022