Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300...

FDA Drug Recall #D-0651-2021 — Class II — June 25, 2021

Recall Summary

Recall Number D-0651-2021
Classification Class II — Moderate risk
Date Initiated June 25, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Kabi USA LLC
Location Melrose Park, IL
Product Type Drugs
Quantity 234,800 vials

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.

Distribution Pattern

Distributed Nationwide in the USA

Lot / Code Information

Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022

Other Recalls from Fresenius Kabi USA LLC

Recall # Classification Product Date
D-0856-2021 Class II Morphine Sulfate Injection, USP, 2 mg per mL, 1... Sep 17, 2021
D-0247-2015 Class III HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL... Apr 14, 2014

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.