FDA Drug recall D-0204-2021
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…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of 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… by Sca Pharmaceuticals, citing lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0204-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-17 |
| Published | 2021-01-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
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
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | Lot # 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 122…Lot # 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 1220023038, BUD 1/20/2021; 1220023074, 1/24/2021; 1220023103, BUD 1/24/2021; 1220023160, BUD 1/26/2021; 1220023180, BUD 1/27/2021; 1220023183, BUD 1/27/2021; 1220023216, BUD 1/28/2021; 1220023267, BUD 2/1/2021; 1220023272, BUD 1/3/2021; 1220023344, BUD 2/10/2021; 1220023387, BUD 2/9/2021; 1220023475,BUD 2/4/2021; 1220023479, BUD 2/4/2021; 1220023564, BUD 2/9/2021; 1220023565, BUD 2/9/2021; 1220023587, BUD 2/10/2021 & 1220023624, BUD 2/11/2021. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0204-2021%22
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