Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Acetaminophen Oral Solution Recalled by Plastikon Healthcare LLC Due to CGMP Deviations: Failure to properly investigate failed microbial...

Date: March 24, 2022
Company: Plastikon Healthcare LLC
Status: Completed
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Plastikon Healthcare LLC directly.

Affected Products

Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.

Quantity: 121,800 Unit Dose cups

Why Was This Recalled?

CGMP Deviations: Failure to properly investigate failed microbial testing.

Where Was This Sold?

Distributed in Indiana for further distribution in the USA.

About Plastikon Healthcare LLC

Plastikon Healthcare LLC has 25 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report