Ultra Seal Corporation recalls AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in…

Recall date

October 13, 2021

Source

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

Recall number

D-0073-2022

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

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )