EPINEPHRINE BITARTRATE Recall D-1053-2022
Description: Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27
EPINEPHRINE BITARTRATE Recall D-1053-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1053-2022 |
| Event ID | 89646 |
| Brand | XYLOCAINE |
| Generic Name | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
| Manufacturer | LIDOCAINE HYDROCHLORIDE,EPINEPHRINE BITARTRATE |
| Original Package? | 1 |
| Active Substance | EPINEPHRINE BITARTRATE LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Drug Route | INFILTRATION |
| Distribution | USA nationwide. |
| Quantity | 33 trays/25 vials per tray |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 63323-481 63323-492 63323-491 |
| Drug UPC | 0363323484576 0363323485016 0363323483036 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 30Q7KI53AK EC2CNF7XFP |
| Drug Application Number | NDA006488 |
| Structured Product Labeling (SPL ID) | ea480a68-5927-4278-9deb-2956961da428 |
| Structured Product Labeling (SPL Set ID) | ba082c2f-64f4-419d-9c88-74f203316e17 |
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