FDA-Drug2015-03-18Class II
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.
Fusion Pharmaceuticals, LLC
Hazard
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Sold states
California
Affected count
9,439 Kits
Manufactured in
768 Calle Plano Suite A, N/A, Camarillo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0410-2015Don't want to check this manually?
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