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.
Reason for recall: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Recall initiated: 20150306
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated