Drug & medication recalls Moderate risk

PAINAID 2 tablet packets recalled over manufacturing violations

Recall date
January 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ultra Seal Corporation recalls PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medi…
Recall number
D-0492-2022
FDA classification
Class II
Brand / firm
Ultra Seal Corporation
Sold / distributed
Nationwide within the United States

Why it was recalled

cGMP deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PAINAID (acetaminophen 110 mg, aspirin 162mg, caffeine 32.4 mg, salicylamide 152mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040

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