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Recall Observatory FDA recall evidence

Drug 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

D-1585-2019

June 25, 2019

Class III

Product summary

Firm
AAA Pharmaceutical, Inc.
Event
Event 83210
Status
Terminated
Classification
Class III
Quantity
a) 288 bottles b) 48 bottles
Official record key
drug-enforcement:D-1585-2019

Official wording

Reason: 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.

Code information: a) P136370, exp 9/2022 b) P136366, exp 9/2022

Distribution pattern: KS

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling; Incorrect or Missing