FDA recall D-0358-2021

A-S Medication Solutions LLC. · Class I · drug

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 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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-03-02
Report date
2021-05-12
Termination date
2025-04-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Libertyville, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0358-2021