FDA Drug recall D-1089-2020
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Bar…
- FDA Drug
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Bar… by Pharmedium Services, citing firm is recalling 46 lots of various products because of a lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1089-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-16 |
| Published | 2020-04-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pharmedium Services |
| Distribution | US |
Product
fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,500 mcg per 30 mL, 30 mL Total Volume, in a 35 mL Monoject Barrel Syringe, PharMEDium Services, LLC 913 N. Davis Avenue Cleveland, MS 38732. NDC 61553-672-44
Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Identifiers
| code_info | 193510008D 3/17/2020 193580004D 3/25/020 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1089-2020%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.