Ultra Seal Corporation recalls Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/packag…

Recall date

October 13, 2021

Source

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

Recall number

D-0076-2022

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

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)