DICOPANOL FusePaq recalled over sterility concerns
- Recall date
- March 6, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Fusion Pharmaceuticals, LLC recalls DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmace…
- Recall number
- D-0410-2015
- FDA classification
- Class II
- Brand / firm
- Fusion Pharmaceuticals, LLC
- Sold / distributed
- California
Why it was recalled
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
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