FDA Recall D-0358-2021

A-S Medication Solutions LLC. · Libertyville, IL

Class I — life-threatening Terminated 1513 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: 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

Quantity: 201,600 kits

Reason for recall

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.

Recall record

Recall number: D-0358-2021
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA
Recall initiated: 2021-03-02
Classified by FDA Center: 2021-04-30
FDA published: 2021-05-12
Terminated: 2025-04-23
Recalling firm: A-S Medication Solutions LLC.
Firm location: Libertyville, IL

Drug identification

Brand name(s): ACETAMINOPHEN
Generic name(s): ACETAMINOPHEN
Manufacturer(s): A-S Medication Solutions
NDC(s): 50090-5350
Route(s): ORAL

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