Why it was recalled
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.
Product description
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
Lot numbers, UPCs & expiration codes
a) P136370, exp 9/2022 b) P136366, exp 9/2022
Where it was sold
KS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1585-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 25, 2019
- FDA report date
- Aug 14, 2019
- Quantity
- a) 288 bottles b) 48 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AAA Pharmaceutical, Inc.
Original FDA data
Every field from FDA enforcement report D-1585-2019, exactly as published.
Show all FDA fields
- City
- Lumberton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83210
- Address
- 681 Main St
- Code information
- a) P136370, exp 9/2022 b) P136366, exp 9/2022
- Postal code
- 08048-5013
- Report date
- Aug 14, 2019
- Product type
- Drugs
- Recall number
- D-1585-2019
- Classification
- Class III
- Recalling firm
- AAA Pharmaceutical, Inc.
- Product quantity
- a) 288 bottles b) 48 bottles
- Termination date
- Dec 16, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- KS
- Recall initiation date
- Jun 25, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2019