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
Reported: July 14, 2021 Initiated: June 25, 2021 #D-0651-2021
Product Description
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.
Details
- Recalling Firm
- Fresenius Kabi USA LLC
- Units Affected
- 234,800 vials
- Distribution
- Distributed Nationwide in the USA
- Location
- Melrose Park, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA LLC. Units affected: 234,800 vials.
Why was this product recalled? ▼
Low out of specification results for epinephrine assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 14, 2021. Severity: Moderate. Recall number: D-0651-2021.
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