Sensorcaine-MPF — Class II drug recall D-0172-2021
Terminated recall by Fresenius Kabi USA, LLC, reported 2020-12-30, distributed nationwide. Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
| Recall number | D-0172-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2020-12-22 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2022-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 4,411 trays |
| Reason classes | potency |
| NDC | 63323-0460, 63323-0460-01, 63323-0460-37, 63323-0462, 63323-0462-01, 63323-0462-02, 63323-0462-04, 63323-0462-17, 63323-0462-31, 63323-0462-37, 63323-0464, 63323-0464-02, 63323-0464-03, 63323-0464-31, 63323-0464-37, 63323-0465, 63323-0465-01, 63323-0465-57, 63323-0466, 63323-0466-01, 63323-0466-02, 63323-0466-31, 63323-0466-37, 63323-0467, 63323-0467-01 and 1 more |
| Lot numbers | 6123760 |
| Expiration dates | 2022-02 |
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 for recall
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0172-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.