FDA Drug recall D-0172-2021
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-4…
- FDA Drug
- Class II
- terminated
- Published 2020-12-30
On 2020-12-30 the FDA classified a Class II recall of Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-4… by Fresenius Kabi Usa, citing subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0172-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-10 |
| Published | 2020-12-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Identifiers
| ndc | 63323-465-01 |
|---|---|
| ndc | 63323-465-57 |
| ndc | 63323-467-01 |
| ndc | 63323-467-57 |
| ndc | 63323-460-01 |
| ndc | 63323-460-37 |
| ndc | 63323-464-02 |
| ndc | 63323-464-37 |
| ndc | 63323-464-03 |
| ndc | 63323-464-31 |
| ndc | 63323-466-01 |
| ndc | 63323-466-37 |
| ndc | 63323-466-02 |
| ndc | 63323-466-31 |
| ndc | 63323-462-04 |
| ndc | 63323-462-17 |
| ndc | 63323-462-01 |
| ndc | 63323-462-37 |
| ndc | 63323-462-02 |
| ndc | 63323-462-31 |
| code_info | Batch # 6123760, Exp 02/2022 |
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-0172-2021%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.