FDA Drug recall D-0197-2021
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbo…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbo… 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-0197-2021 |
| 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 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) Lot # 1220023040, BUD 1/19/2021; 1220023070, BUD 1/…a) Lot # 1220023076, BUD 1/24/2021 & 1220023549, BUD 2/9/2021. b) 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.
Other recalls by Sca Pharmaceuticals
- Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd.,…
FDA Drug · Class II · 2024-04-03 · Sca Pharmaceuticals - labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC…
FDA Drug · Class II · 2024-04-03 · Sca Pharmaceuticals - fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma
FDA Drug · Class II · 2024-04-03 · Sca Pharmaceuticals - PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rain…
FDA Drug · Class II · 2024-04-03 · Sca Pharmaceuticals - fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE…
FDA Drug · Class II · 2024-04-03 · Sca Pharmaceuticals
All Sca Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0197-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.