FDA Drug recall D-1037-2016
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 6004…
- FDA Drug
- Class II
- terminated
- Published 2016-06-22
On 2016-06-22 the FDA classified a Class II recall of Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 6004… by Fresenius Kabi Usa, citing presence of Particulate Matter: Glass particulate found in sterile injectable product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1037-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-25 |
| Published | 2016-06-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
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
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Identifiers
| ndc | 63323-472-03 |
|---|---|
| ndc | 63323-472-17 |
| ndc | 63323-472-01 |
| ndc | 63323-472-37 |
| ndc | 63323-463-01 |
| ndc | 63323-463-57 |
| ndc | 63323-461-01 |
| ndc | 63323-461-57 |
| ndc | 63323-468-02 |
| ndc | 63323-468-37 |
| ndc | 63323-468-01 |
| ndc | 63323-468-17 |
| code_info | Lot #: 6111504, Exp 09/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1037-2016%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.