D-1055-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2014
- Initiation Date
- May 8, 2013
- Termination Date
- January 31, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,200 kits
Product Description
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 Pattern
CA
Code Information
Lots: PL520, PL521, PL522 and PL523