PHENYLephrine HCl 40 mg in 0 — Class II drug recall D-0419-2024
Terminated recall by SCA Pharmaceuticals, LLC, reported 2024-04-03, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0419-2024 |
|---|---|
| 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 | 400 bags |
| Reason classes | sterility |
| NDC | 70004-0825-40 |
| Lot numbers | 1223050005 |
| Expiration dates | 2024-01-13 |
Product
PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0825-40, Bar Code 70004082540.
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-0419-2024. 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.