Reported Feb 12, 2014 · Terminated

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

Fusion Pharmaceuticals, LLC

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: Fusion Pharmaceuticals, LLC · 768 Calle Plano # B · Camarillo, CA · 93012-8555

Is this the product you have?

  • Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Lot codes and dates
  • Lots
    • PL520
    • PL521
    • PL522 and PL523
Amount recalled
1,200 kits

Where it was sold

Why it was recalled

Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.

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 Jan 31, 2014 · Data as of Sep 19, 5:53 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.