Recalls / Class II
Class IID-0651-2021
Product
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37
- 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
- Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Why it was recalled
Low out of specification results for epinephrine assay.
Recalling firm
- Firm
- Fresenius Kabi USA LLC
- Manufacturer
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2020 N Ruby St, Melrose Park, Illinois 60160-1112
Distribution
- Quantity
- 234,800 vials
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-06-25
- FDA classified
- 2021-07-07
- Posted by FDA
- 2021-07-14
- Terminated
- 2022-12-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0651-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.