Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

FDA recall notice · announced February 12, 2014 · Fusion Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: CA
Lot/code information: Lots: PL520, PL521, PL522 and PL523
Quantity: 1,200 kits
Status: Terminated
Products in this recall event:
- Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML (D-1055-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.