Acetaminophen Oral Suspension recalled over manufacturing violations

Recall date

November 1, 2021

Source

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

Official notice title

Precision Dose Inc. recalls Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count…

Recall number

D-0094-2022

FDA classification

Class II

Brand / firm

Precision Dose Inc.

Sold / distributed

Nationwide USA

Why it was recalled

cGMP Deviations: Product manufactured with contaminated raw ingredient.

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 Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Individual cup: 68094-231-59), in a) 30-count case (NDC 30-count case: 68094-231-62), and b) 100-count case (NDC 100-count case: 68094-231-61), Hospital Use Only, Pkg. Precision Dose, Inc., S. Beloit, IL 61080.