FDA Drug recall D-0214-2021
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT,…
- FDA Drug
- Class II
- terminated
- Published 2021-01-13
On 2021-01-13 the FDA classified a Class II recall of fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT,… 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-0214-2021 |
| 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
fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CII, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 barcode 70004020006
Reason
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Identifiers
| code_info | Lot #1220023109, BUD 1/25/2021; 1220023255, BUD 1/26/2021; 1220023256. BUD 1/26/2021; 1220023257, BUD 1/28/2021; 12…Lot #1220023109, BUD 1/25/2021; 1220023255, BUD 1/26/2021; 1220023256. BUD 1/26/2021; 1220023257, BUD 1/28/2021; 1220023334, BUD 2/2/2021 & 1220023518, 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-0214-2021%22
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