FDA Drug recall D-1055-2014
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
- FDA Drug
- Class II
- terminated
- Published 2014-02-12
On 2014-02-12 the FDA classified a Class II recall of Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML by Fusion Pharmaceuticals, citing microbial Contamination of Non-Sterile Products: Fusion Pharmaceuticals is recalling the Dicopanol FusePaq Kit due to Total Yeasts and Molds Count above USP limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1055-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-08 |
| Published | 2014-02-12 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fusion Pharmaceuticals |
| Distribution | CA |
Product
Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML
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.
Identifiers
| code_info | Lots: PL520, PL521, PL522 and PL523 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1055-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.