FDA Drug recall D-0062-2018
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, S…
- FDA Drug
- Class II
- terminated
- Published 2017-11-08
On 2017-11-08 the FDA classified a Class II recall of fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, S… by Sca Pharmaceuticals, citing lack Of Assurance Of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0062-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-19 |
| Published | 2017-11-08 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125% (Total FentaNYL Dose 500 mcg/250 mL) in 0.9% Sodium Chloride 250 mL Bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205. NDC 70004-0231-40
Reason
Lack Of Assurance Of Sterility.
Identifiers
| code_info | Lot: 20170814@20 BUD: 11/12/2017 |
|---|
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-0062-2018%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.