Ultra Seal Corporation recalls ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Table…

Recall date

October 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0072-2022

FDA classification

Class III

Brand / firm

Ultra Seal Corporation

Sold / distributed

Nationwide in the USA.

Why it was recalled

Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)