FDA-Drug2021-11-17Class II
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.
Precision Dose Inc.
Hazard
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Sold states
Nationwide USA
Affected count
166,920 unit dose cups
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0094-2022Don't want to check this manually?
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