PHENYLephrine HCl 100 mcg per mL In 0 — Class II drug recall D-0066-2018
Terminated recall by SCA Pharmaceuticals, LLC, reported 2017-11-08, distributed nationwide. Lack Of Assurance Of Sterility.
| Recall number | D-0066-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, LLC, Little Rock, AR, United States |
| Recall initiated | 2017-10-19 |
| Classified | 2017-11-02 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2019-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,221 syringes |
| Reason classes | sterility |
| NDC | 70004-0810-12 |
| Expiration dates | 2017-12-19 |
Product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
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-0066-2018. 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.