March 2021 FDA Recall Acetaminophen by A-s Medication Solutions Llc.
D-0358-2021 - Labeling

This Class I drug recall was voluntarily initiated by A-s Medication Solutions Llc. on March 2, 2021 for the product Acetaminophen. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0358-2021

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.
Initiated
03-02-2021
Reported
05-12-2021
Quantity
201,600 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87436
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
A-S Medication Solutions LLC.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-23-2025
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# 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

Affected Packages Involved in this Recall

50090-5350-0 Acetaminophen
50090-5350-1 Acetaminophen