FDA-Drug2013-04-24Class II

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.

Precision Dose Inc.
Hazard

Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen contained within it, is an adult dose.

Sold states
Nationwide and Puerto Rico
Affected count
9,268 cases
Manufactured in
722 Progressive Ln, N/A, South Beloit, IL, United States
Products
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL 61080.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-250-2013

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