Ultra Seal Corporation recalls Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufa…

Recall date

August 3, 2020

Source

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

Recall number

D-1512-2020

FDA classification

Class III

Brand / firm

Ultra Seal Corporation

Sold / distributed

Product was shipped to two distributors in IL and TX who may have further repackaged and distributed the product.

Why it was recalled

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

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

What was recalled

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007