PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0 — Class II drug recall D-0216-2021
Terminated recall by SCA Pharmaceuticals, reported 2021-01-13, distributed nationwide. Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
| Recall number | D-0216-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SCA Pharmaceuticals, Windsor, CT, United States |
| Recall initiated | 2020-12-17 |
| Classified | 2021-01-07 |
| Reported by FDA | 2021-01-13 |
| Terminated | 2021-11-02 |
| Distributed | Nationwide (US) |
| Quantity | 3,152 syringes |
| Reason classes | sterility |
| Lot numbers | 1220023003, 1220023057, 1220023104, 1220023144, 1220023168, 1220023222, 1220023240, 1220023284, 1220023456, 1220023474, 1220023530, 1220023542 |
| Expiration dates | 2020-12-22, 2020-12-25, 2020-12-27, 2020-12-28, 2020-12-29, 2021-01-01, 2021-01-04, 2021-01-08, 2021-01-09 |
Product
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081022
Reason for recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
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-0216-2021. 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.