Recalls / Class I
Class ID-0358-2021
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.
- Brand name
- Acetaminophen
- Generic name
- Acetaminophen
- Active ingredient
- Acetaminophen
- Route
- Oral
- NDC
- 50090-5350
- FDA application
- M013
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- A-S Medication Solutions LLC.
- Manufacturer
- A-S Medication Solutions
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 2401 Commerce Dr, N/A, Libertyville, Illinois 60048-4464
Distribution
- Quantity
- 201,600 kits
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-02
- FDA classified
- 2021-04-30
- Posted by FDA
- 2021-05-12
- Terminated
- 2025-04-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0358-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.