Reported Nov 8, 2017 · Terminated

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per…

Precision Dose Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only
  • PkgPrecision Dose, Inc., S. Beloit, IL 61080
Lot codes and dates
  • Lot number
    • 500105
    • Exp 04/30/18
Amount recalled
801 cases

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: low out of specification results.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 23, 2018 · Data as of Sep 19, 4:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.