FDA Drug recall D-1085-2020
fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC…
- FDA Drug
- Class II
- terminated
- Published 2020-04-15
On 2020-04-15 the FDA classified a Class II recall of fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC… 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-1085-2020 |
| 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 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare Bag, in Sodium Chloride 0.9%. Rx Only, PharMEDium Services, LLC 913 N. Davis Ave Cleveland, MS 36732 NDC 61553-113-50
Reason
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Identifiers
| code_info | 193610002D, Exp 3/29/2020 |
|---|
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-1085-2020%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.