FDA Drug recall D-0358-2021
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152
- FDA Drug
- Class I
- terminated
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class I recall of Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152 by A S Medication Solutions, citing labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription dr….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0358-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-03-02 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | A S Medication Solutions |
| Distribution | US |
Product
Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottles, Mfr: Major Pharmaceuticals, Livonia, MI 48152; Packaged Exclusively By: A-S Medication Solutions LLC, Libertyville, IL 60048, Product # 6967-0; NDC: 50090-5350-0; contained within Health Essentials Kit, Kit Contains: 1 bottle hand sanitzer, 1 reusable face mask, 1 bottle Acetaminophen 500 mg, 1 bag cough drops, 1 digital thermometer, 50 disposable gloves.
Reason
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Identifiers
| ndc | 50090-5350-0 |
|---|---|
| ndc | 50090-5350-1 |
| code_info | Lots 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359,335360, 335361, 335362, 335395, 352116, Exp…Lots 323206, 323207, 323208, 335353, 335354, 335355, 335356, 335358, 335359,335360, 335361, 335362, 335395, 352116, Expiry 7/31/2022; 323209, 323210, 323211, 323212, 323213, 323214, 323215, 323216, 323218, 323219, 323220, 323222, 323223, 323224, 323238, 335363, 335364, 335365, 335366, 335367, 335368, 335369, 335370, 335371, 335372, 335373, 335374, 335375, 335376, 335377, Expiry 8/31/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0358-2021%22
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