PHENYLephrine HCl 50 mg in 0 — Class II drug recall D-1133-2015
Terminated recall by SCA Pharmaceuticals, reported 2015-06-17, distributed in CA. Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather t
| Recall number | D-1133-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Little Rock, AR, United States |
| Recall initiated | 2015-04-28 |
| Classified | 2015-06-10 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-12-09 |
| Distributed | CA |
| Quantity | 50 bags |
| Reason classes | labeling |
| Expiration dates | 2015-07-22 |
Product
PHENYLephrine HCl 50 mg in 0.9% Sodium Chloride 250 mL bag (Concentration = 0.2 mg per mL), Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR (877) 550-5059, barcode 88888772029.
Reason for recall
Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.
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-1133-2015. 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.