FDA Drug recall D-0410-2015
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only
- FDA Drug
- Class II
- terminated
- Published 2015-03-18
On 2015-03-18 the FDA classified a Class II recall of DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only by Fusion Pharmaceuticals, citing microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0410-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-06 |
| Published | 2015-03-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fusion Pharmaceuticals |
| Distribution | CA |
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
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.
Identifiers
| code_info | Lot Numbers: PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, P…Lot Numbers: PL713, PL714, PL715, PL716, PL717, PL718, PL719, PL720, PL721, PL722, PL735, PL736, PL737, PL738, PL739, PL740, PL741, PL742, PL743, PL744; Expiry: 7/20/2015. |
|---|
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-0410-2015%22
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