FentaNYL 500 mcg/250 mL — Class II drug recall D-0945-2023
Terminated recall by SCA Pharmaceuticals, reported 2023-08-02, distributed in KY, NJ. cGMP deviations: due to shipment of rejected units.
| Recall number | D-0945-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2023-07-20 |
| Classified | 2023-07-26 |
| Reported by FDA | 2023-08-02 |
| Terminated | 2023-09-21 |
| Distributed | KY, NJ |
| Quantity | 183 bags |
| Reason classes | cgmp |
| NDC | 70004-0253-40 |
| Lot numbers | 1223047134 |
| Expiration dates | 2023-09-21 |
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 for recall
cGMP deviations: due to shipment of rejected units.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0945-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.