PHENYLephrine HCl 1000 mcg/10 mL in 0 — Class II drug recall D-0204-2021
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-0204-2021 |
|---|---|
| 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 | 23,029 syringes |
| Reason classes | sterility |
| Lot numbers | 1220022957, 1220022993, 1220023020, 1220023037, 1220023038, 1220023074, 1220023103, 1220023160, 1220023180, 1220023183, 1220023216, 1220023267, 1220023272, 1220023344, 1220023387, 1220023475, 1220023479, 1220023564, 1220023565, 1220023587, 1220023624 |
| Expiration dates | 2021-01-03, 2021-01-14, 2021-01-19, 2021-01-20, 2021-01-21, 2021-01-24, 2021-01-26, 2021-01-27, 2021-01-28, 2021-02-01, 2021-02-04, 2021-02-09, 2021-02-10, 2021-02-11 |
Product
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
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-0204-2021. 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.