Fusion Pharmaceuticals, LLC recalls DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmace
Recalled March 18, 2015 · FDA recall D-0410-2015 · Fusion Pharmaceuticals
Hazard
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans. · FDA Class II
Units
9,439 Kits
Sold at
California
Description
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Product
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.
Manufacturer(s)
Fusion Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →