Drug & medication recalls Moderate risk

Acetaminophen 325 mg tablets recalled over manufacturing violations

Recall date
June 16, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Spirit Pharmaceuticals recalls Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentovill…
Recall number
D-0729-2021
FDA classification
Class II
Brand / firm
Spirit Pharmaceuticals
Sold / distributed
USA Nationwide

Why it was recalled

cGMP deviations: Discolored acetaminophen

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

What was recalled

Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10

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