FDA recall D-1055-2014
Fusion Pharmaceuticals, LLC · Class II · drug
Product
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
Reason for recall
Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Distribution
CA
Key facts
- Status
- Terminated
- Initiation date
- 2013-05-08
- Report date
- 2014-02-12
- Termination date
- 2014-01-31
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Camarillo, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1055-2014