Dicopanol FusePaq Kit for Oral Suspension — Class II drug recall D-1055-2014
Terminated recall by Fusion Pharmaceuticals, LLC, reported 2014-02-12, distributed in CA. Microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit
| Recall number | D-1055-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fusion Pharmaceuticals, LLC, Camarillo, CA, United States |
| Recall initiated | 2013-05-08 |
| Classified | 2014-01-31 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2014-01-31 |
| Distributed | CA |
| Quantity | 1,200 kits |
| Reason classes | microbial contamination, sterility |
| Lot numbers | PL520, PL521, PL522, PL523 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1055-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.