Sensorcaine- MPF — Class II drug recall D-1037-2016
Terminated recall by Fresenius Kabi USA, LLC, reported 2016-06-22, distributed nationwide. Presence of Particulate Matter: Glass particulate found in sterile injectable product
| Recall number | D-1037-2016 |
|---|---|
| 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 | 2016-04-25 |
| Classified | 2016-06-16 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 69,225 units |
| Reason classes | foreign material, sterility, specification failure |
| NDC | 63323-0461, 63323-0461-01, 63323-0461-57, 63323-0463, 63323-0463-01, 63323-0463-57, 63323-0468, 63323-0468-01, 63323-0468-02, 63323-0468-17, 63323-0468-37, 63323-0472, 63323-0472-01, 63323-0472-03, 63323-0472-17, 63323-0472-37 |
| Lot numbers | 6111504 |
| Expiration dates | 2019-09 |
Product
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Reason for recall
Presence of Particulate Matter: Glass particulate found in sterile injectable product
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-1037-2016. 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.