DICOPANOL — Class II drug recall D-0410-2015
Terminated recall by Fusion Pharmaceuticals, LLC, reported 2015-03-18, distributed in CA. Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
| Recall number | D-0410-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fusion Pharmaceuticals, LLC, Camarillo, CA, United States |
| Recall initiated | 2015-03-06 |
| Classified | 2015-03-12 |
| Reported by FDA | 2015-03-18 |
| Terminated | 2015-10-27 |
| Distributed | CA |
| Quantity | 9,439 kits |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 43093-0104-01 |
| Lot numbers | PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, PL740, PL741, PL742, PL743, PL744 |
| Expiration dates | 2015-07-20 |
Product
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only. Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Reason for recall
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
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-0410-2015. 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.