FDA Drug recall D-0198-2021
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd.,…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd.,… 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-0198-2021 |
| 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
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | Lot # 1220022969, BUD 3/1/2021; 1220023002, BUD 3/2/2021; 1220023045, BUD 3/2/2021; 1220023081, BUD 3/2/2021; 1220023…Lot # 1220022969, BUD 3/1/2021; 1220023002, BUD 3/2/2021; 1220023045, BUD 3/2/2021; 1220023081, BUD 3/2/2021; 1220023130, BUD 3/6/2021; 1220023229, BUD 3/9/2021; 1220023287, BUD 3/12/2021 & 1220023335, BUD 3/22/2021. |
|---|
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-0198-2021%22
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