FDAClass IIJanuary 9, 2019

Lidocaine gel 1% recall: Sterility Concern

Lidocaine gel 1%, RX, plastic dropper

Why was Lidocaine gel 1% recalled?

Lack of sterility assurance.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

10222018@40

Product
Lidocaine gel 1%, RX, plastic dropper
Recalling firm
Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
Quantity
N/A
Distribution
Product was distributed exclusively in the state of Oregon to 3 Medical facilities, 1 Physician's office and 80 consumers/patients. These are compounded products - labels vary for each compound - specific to each patient. Firm did not provide labeling.
Recall date
January 9, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls