Key Takeaway
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. by Fusion Pharmaceuticals, LLC was recalled on March 6, 2015. The hazard: Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
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.
Description
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.
Hazard / Reason
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
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.
DrugsCompany Information
Fusion Pharmaceuticals, LLC
Camarillo, CA, United States
View all 2 recalls by Fusion Pharmaceuticals, LLC →Distribution
California
Related Recalls
Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.