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
Product summary
- 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
Labeling; Incorrect or Missing