Reported Aug 9, 2017 · Terminated

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL…

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?

  • Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only
  • PkgPrecision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59
Lot codes and dates
    • Lot #: 500326
    • Exp. 6/30/2018
Amount recalled
480 (5mL) unit dose cups

Where it was sold

Why it was recalled

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

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 Mar 28, 2018 · Data as of Sep 19, 4:17 PM UTC

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