PRODUCT
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML, Rx only, (NDC 43093-104-01)

CODE
PL520, PL521, PL522 and PL523 Exp. 08/13

RECALLING FIRM
Fusion Pharmaceuticals, LLC, Camarillo, CA


REASON FOR RECALL
Lack of Assurance of Sterility: Total Yeasts and Molds Count (TYMC) for a component within the Dicopanol FusePaq Kit which is outside the acceptance criteria