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FDAFDA · Food and drugs·Recall number D-0094-2022

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.

Published November 17, 2021 · Recall initiated: November 1, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

cGMP Deviations: Product manufactured with contaminated raw ingredient.

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
ACETAMINOPHEN
Manufacturer
Precision Dose Inc.
Distributor
Nationwide USA
Lot
Lot#: 503670
Risk classification
Class II
Area (FDA)
drug
Country
United States

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