Food, drugs, devices › AAA Pharmaceutical, Inc.
Drug recall: Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count UPC 8-8397-38781-6 and b) 500 count UPC 8-83
FDA enforcement event 83210 is a drug recall by AAA Pharmaceutical, Inc. of Lumberton, NJ, initiated 25 Jun 2019 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 16 Dec 2020. Initiation: voluntary: firm initiated. AAA Pharmaceutical, Inc. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AAA Pharmaceutical, Inc., Lumberton, NJ.
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."
Distribution
"KS"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1585-2019 | 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 | a) 288 bottles b) 48 bottles | Class III | Terminated | 14 Aug 2019 |
Context
Other enforcement events for AAA Pharmaceutical, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Feb 2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg /Antihistamine, Indoor/Outdoor Allergies, | Drug | Class III | 1 |
| 26 Dec 2019 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | Drug | Class II | 2 |
All 3 events for AAA Pharmaceutical, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives 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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "KS"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Dec 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.