FDA Drug recall D-1053-2022
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27
- FDA Drug
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27 by Mckesson Medical Surgical Corporate Office, citing cGMP deviations: Temperature abuse.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1053-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-13 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
Product
Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27
Reason
cGMP deviations: Temperature abuse
Identifiers
| ndc | 63323-492-04 |
|---|---|
| ndc | 63323-492-27 |
| ndc | 63323-492-09 |
| ndc | 63323-492-57 |
| ndc | 63323-492-07 |
| ndc | 63323-492-37 |
| ndc | 63323-492-03 |
| ndc | 63323-492-31 |
| ndc | 63323-491-01 |
| ndc | 63323-491-57 |
| ndc | 63323-495-09 |
| ndc | 63323-495-27 |
| ndc | 63323-495-04 |
| ndc | 63323-495-07 |
| ndc | 63323-485-01 |
| ndc | 63323-485-27 |
| ndc | 63323-485-03 |
| ndc | 63323-485-57 |
| ndc | 63323-486-01 |
| ndc | 63323-486-17 |
| ndc | 63323-486-02 |
| ndc | 63323-486-27 |
| ndc | 63323-486-05 |
| ndc | 63323-486-57 |
| ndc | 63323-484-57 |
| ndc | 63323-489-02 |
| ndc | 63323-489-27 |
| ndc | 63323-489-03 |
| ndc | 63323-489-21 |
| ndc | 63323-489-01 |
| ndc | 63323-489-17 |
| ndc | 63323-488-07 |
| ndc | 63323-488-37 |
| ndc | 63323-488-03 |
| ndc | 63323-488-31 |
| ndc | 63323-488-01 |
| ndc | 63323-488-17 |
| ndc | 63323-481-01 |
| ndc | 63323-481-57 |
| ndc | 63323-483-03 |
| ndc | 63323-483-27 |
| ndc | 63323-483-01 |
| ndc | 63323-483-57 |
| ndc | 63323-482-01 |
| ndc | 63323-482-17 |
| ndc | 63323-482-03 |
| ndc | 63323-482-27 |
| ndc | 63323-482-05 |
| ndc | 63323-482-57 |
| ndc | 63323-487-01 |
| ndc | 63323-487-17 |
| ndc | 63323-487-07 |
| ndc | 63323-487-37 |
| ndc | 63323-487-03 |
| ndc | 63323-487-31 |
| code_info | McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee fo…McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. |
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-1053-2022%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.