FDA Drug recall D-0874-2017
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100…
- FDA Drug
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100… by Sca Pharmaceuticals, citing lack of assurance of sterility: Product bags leaking at seam.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0874-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-18 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32
Reason
Lack of assurance of sterility: Product bags leaking at seam.
Identifiers
| code_info | LOT # 20170508@59, Use By: 08/06/17 |
|---|
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-0874-2017%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.