Class II · Moderate risk
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit)
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Dicopanol FusePaq Kit for Oral Suspension
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
- Recalling firm
- Fusion Pharmaceuticals, LLC
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1055-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Fusion Pharmaceuticals, LLC
All 2013 recallsOther microbial contamination recalls from 2013
All microbial contamination recalls
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