Drug product
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
D-1055-2014
Product summary
- Event
- Event 66139
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,200 kits
- Official record key
drug-enforcement:D-1055-2014
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Code information: Lots: PL520, PL521, PL522 and PL523
Distribution pattern: CA
Derived failure modes
-
Microbial contamination
Microbial Contamination