FDA Drug recall D-0217-2021
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow R…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow R… 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-0217-2021 |
| 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
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043009
Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1…Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/21/2021; 1220023105, BUD 1/25/2021; 1220023158, BUD 1/26/2021; 1220023315, BUD 2/1/2021; 1220023342, BUD 2/2/2021; 1220023431, BUD 2/4/2021; 1220023471, BUD 2/3/2021; 1220023481, BUD 2/4/2021 & 1220023509, BUD 2/8/2021. |
|---|
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-0217-2021%22
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