PHENYLephrine 20 mg in 0 — Class II drug recall D-1030-2017
Terminated recall by SCA Pharmaceuticals, reported 2017-08-02, distributed nationwide. Lack of Assurance of Sterility; product has the potential to leak.
| Recall number | D-1030-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Little Rock, AR, United States |
| Recall initiated | 2017-07-14 |
| Classified | 2017-07-26 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| NDC | 70004-0816-40 |
| Expiration dates | 2017-08-01 |
Product
PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
Reason for recall
Lack of Assurance of Sterility; product has the potential to leak.
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-1030-2017. 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.