Accucaine, Kit contains: Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL single dose ampule, Rx Only, Distributed by En
Manufacturer / Brand: Asclemed USA Inc.
Reason for Recall
Lack of Assurance of Sterility
Date Issued
Category
Medications
Status
unknown
Issuing Agency
FDA CDER
About sterility and contamination recalls
Sterility recalls for medications are issued when injectable, ophthalmic, or other sterile drug products are found to be contaminated with bacteria, fungus, or particulate matter — or when they fail sterility testing. Non-sterile injectable drugs can cause serious infections, sepsis, or meningitis. These recalls are treated as among the most urgent in the pharmaceutical category.
⚠ Stop using the product immediately. If you have already administered the product, monitor for signs of infection including fever, chills, or pain at the injection site, and contact your healthcare provider.
What to do if you're affected
- →Check the lot number on your medication package against the specific lots listed in the recall notice — not every batch is always affected.
- →Do not stop a prescription medication without first consulting your doctor or pharmacist. Abrupt discontinuation of some drugs carries serious risks.
- →Contact your pharmacy — they can verify whether your dispensed lot is affected and arrange a replacement prescription.
- →For most insurance plans, a replacement fill triggered by a recall is covered even before the normal refill date.
- →Report any adverse effects to the FDA at 1-800-FDA-1088 or through MedWatch at fda.gov/safety/medwatch.
About the FDA CDER
This recall was issued by or conducted in cooperation with the FDA's Center for Drug Evaluation and Research (CDER), which oversees prescription and over-the-counter medications sold in the United States. Drug recalls may be initiated voluntarily by the manufacturer or at FDA's request after a quality problem is identified through manufacturer testing, FDA inspection, or adverse event reports. Recalls are classified by severity: Class I involves products that may cause serious injury or death; Class II and III involve lower levels of risk. Do not stop a prescription medication due to a recall without first consulting your doctor or pharmacist.
View all FDA CDER recalls →Opens the official government source. Always refer to official sources for the most current information.