FDA Drug recall D-0945-2023
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mc…
- FDA Drug
- Class II
- terminated
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mc… by Sca Pharmaceuticals, citing cGMP deviations: due to shipment of rejected units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0945-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-20 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | KY, NJ |
Product
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL Concentration - 2 mcg/mL), Rx Only, Single Dose Container, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC# 70004-0253-40
Reason
cGMP deviations: due to shipment of rejected units.
Identifiers
| code_info | Lot # 1223047134, Use By: 09/21/2023 |
|---|
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-0945-2023%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.