Recalls / Class II
Class IID-1052-2022
Product
Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC
- Brand name
- Xylocaine
- Generic name
- Lidocaine Hydrochloride,epinephrine Bitartrate
- Active ingredients
- Epinephrine Bitartrate, Lidocaine Hydrochloride Anhydrous
- Route
- Infiltration, Perineural
- NDCs
- 63323-481, 63323-492, 63323-491, 63323-495, 63323-485, 63323-486, 63323-484, 63323-489, 63323-488, 63323-483 +2 more
- FDA application
- NDA006488
- Affected lot / code info
- 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.
Why it was recalled
cGMP deviations: Temperature abuse
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 76 trays/25 vials per tray
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2022-04-13
- FDA classified
- 2022-06-09
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1052-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.