fentaNYL 200 mcg/100 mL — Class II drug recall D-0398-2024
Terminated recall by SCA Pharmaceuticals, LLC, reported 2024-04-03, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0398-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, LLC, Windsor, CT, United States |
| Recall initiated | 2023-11-09 |
| Classified | 2024-03-22 |
| Reported by FDA | 2024-04-03 |
| Terminated | 2024-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 613 cassettes |
| Reason classes | sterility |
| NDC | 70004-0231-64 |
| Lot numbers | 1223049754, 1223049992, 1223050066 |
| Expiration dates | 2024-01-12, 2024-01-23, 2024-01-25 |
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164
Reason for recall
Lack of Assurance of Sterility
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-0398-2024. 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.