FDAClass IIMarch 30, 2022

Lidocaine Cream 4% recall: CGMP Deviations

Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.

Why was Lidocaine Cream 4% recalled?

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

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?

Batch: 15722, Exp. 6/30/2022; 16274, Exp. 12/31/2022; 16947, Exp. 5/31/2023; 17140, Exp. 8/31/2023

Product
Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
Recalling firm
Teligent Pharma, Inc.
Quantity
48,907 tubes
Distribution
Nationwide in the USA and Puerto Rico
Recall date
March 30, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls