Drug & medication recalls Moderate risk

Family Dollar Stores product recalled over manufacturing violations

Recall date
March 31, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Family Dollar Stores, Llc. recalls Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplet…
Recall number
D-0565-2023
FDA classification
Class II
Brand / firm
Family Dollar Stores, Llc.
Sold / distributed
Nationwide within the United States

Why it was recalled

CGMP deviation: product outside labeled storage temperature requirements.

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

What was recalled

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

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