FDAFDA · Food and drugs·Recall number D-1055-2014
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Published February 12, 2014 · Recall initiated: May 8, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fusion Pharmaceuticals, LLC
- Distributor
- CA
- Lot
- Lots: PL520, PL521, PL522 and PL523
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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