FDA Drug recall D-0363-2023
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Contain…
- FDA Drug
- Class III
- terminated
- Published 2023-03-08
On 2023-03-08 the FDA classified a Class III recall of Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Contain… by Sca Pharmaceuticals, citing subpotent Drug.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0363-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-02-24 |
| Published | 2023-03-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sca Pharmaceuticals |
| Distribution | US |
Product
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Reason
Subpotent Drug
Identifiers
| code_info | Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, ex…Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023 |
|---|
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-0363-2023%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.