Limited Recall (4 lots) for Lidocaine Ampules

URGENT: DRUG RECALL
LIDOCAINE HCL Injection USP 1% 10mg/mL 5mL Ampules, USP

Dear Customer:

A voluntary recall notice for Lidocaine HCL Injection USP 1% 10mg/mL 5mL Ampules (Lidocaine Ampule) was issued by Huons Co, Ltd, the contract manufacturer, to Spectra Medical Devices on April 1, 2026.  

The reason for recall by the contract manufacturer is due to quality issues identified during a recent FDA manufacturing inspection of its drug manufacturing site. Based upon review of the quality issues reported, Spectra Medical Devices has submitted its retained samples to independently verify product quality with respect to endotoxin and sterility release criteria for all Lidocaine Ampule lots that are within their expiry period. All lots met the release criteria for endotoxin. Lots listed below did not meet release criteria for sterility.

The product risk has been determined to be low, as the terminal sterilization overkill process provides a very high level of sterility assurance. As noted above, all lots meet release requirements for endotoxin testing during independent testing. Since April 1, 2023, two (2) potentially related complaints for efficacy have been received by Spectra; no complaints have been received by Spectra related to sterility or endotoxin concerns.

Regardless, because we cannot definitively prove the testing laboratory caused the result, and out of an abundance of caution, Spectra Medical Device, LLC is recalling this limited list of lots. All other lots not listed within their expiry period passed independent sterility and endotoxin verification testing and are not within the scope of this recall.

Product Affected:

Our records indicate that you received one or more of these lots from Spectra, with distribution dates ranging from October 23, 2024, through March 23, 2026. Importantly, please note that if a lot is not listed below, such lot(s) were not affected and are not subject to this recall.

Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall, including instructions on how to handle unused product; specifically, return the ampules as instructed below. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Please immediately examine your stock and return any unexpired, unused Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules bearing the listed lot numbers to:

Spectra Medical Devices, LLC
ATTENTION: QUALITY ASSURANCE DEPARTMENT
299 Ballardvale Street, Suite 1,
Wilmington, MA 01887

Please complete the mandatory attached Recall Response Form to enable us to complete recall effectiveness evaluation. This form must be returned by trackable mail, also billed to Spectra Medical, or via e-mail to RecallCoordinator@elevarismedical.com. Spectra will credit your account for any returned product that is unused and unexpired. Billing information for return product shipment is available by contacting: RecallCoordinator@elevarismedical.com. This email is monitored between 8 am to 4:30 pm Eastern Time.

PLEASE FILL OUT AND RETURN THE RECALL RESPONSE FORM EVEN IF YOU HAVE NONE OF THESE ITEMS ON HAND.

This recall is expected to be performed to the wholesale, hospital and / or medical practitioner / healthcare provider levels.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being made with the knowledge of the Food and Drug Administration.

We sincerely regret the inconvenience this will cause you, but we know that you share with us the desire to maintain the highest quality standards in our products.

Sincerely,

Lisa A. Perronne
VP Quality & Regulatory

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