Drug recall D-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
Reason for recall
Low out of specification results for epinephrine assay.
Lots and codes
Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022
Recall details
- Recalling firm
- Fresenius Kabi USA LLC, Melrose Park, IL
- Quantity
- 234,800 vials
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 25, 2021
- Terminated
- December 28, 2022
Related products
- Xylocaine – drug information
- NDC 63323-484 Xylocaine · Lidocaine Hydrochloride Anhydrous 5 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-492 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 10 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-483 Xylocaine · Lidocaine Hydrochloride Anhydrous 20 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-487 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 10 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-489 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 20 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-495 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 20 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-481 Xylocaine · Lidocaine Hydrochloride Anhydrous 5 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-485 Xylocaine · Lidocaine Hydrochloride Anhydrous 10 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-488 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 15 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-482 Xylocaine · Lidocaine Hydrochloride Anhydrous 10 mg/mL; Epinephrine… · Fresenius Kabi USA, LLC
- NDC 63323-486 Xylocaine · Lidocaine Hydrochloride Anhydrous 20 mg/mL · Fresenius Kabi USA, LLC
- NDC 63323-491 Xylocaine MPF · Lidocaine Hydrochloride Anhydrous 5 mg/mL · Fresenius Kabi USA, LLC