Reported Apr 24, 2013 · Terminated

Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups…

Precision Dose Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Precision Dose Inc. · 722 Progressive Ln · South Beloit, IL · 61080-2616

Is this the product you have?

  • 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
  • ByPrecision Dose, Inc., S. Beloit, IL 61080
Lot codes and dates
    • Lot #: 101456
    • Exp 05/13
    • 101488
  • Exp 06/13
    • 101499
    • 101503
    • Exp 07/13
    • 101537
    • 101552
    • 101554
    • Exp 08/13
    • 101611
    • 101616
    • 101623
    • Exp 10/13
    • 101630
    • Exp 11/13
    • 101754
    • Exp 03/14
Amount recalled
9,268 cases

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 7, 2015 · Data as of Sep 19, 7:19 PM UTC

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