PHENYLephrine HCl 500 mcg/5mL in 0 — Class II drug recall D-0210-2021
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-0210-2021 |
|---|---|
| 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 | 14,580 syringes |
| Reason classes | sterility |
| Lot numbers | 1220022958, 1220023013, 1220023035, 1220023036, 1220023059, 1220023094, 1220023167, 1220023208, 1220023291, 1220023359, 1220023401, 1220023473 |
| Expiration dates | 2021-01-18, 2021-01-19, 2021-01-20, 2021-01-21, 2021-01-25, 2021-01-26, 2021-01-27, 2021-01-31, 2021-02-02, 2021-02-04 |
Product
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
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-0210-2021. 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.