PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: March 30, 2022 Initiated: March 15, 2022 #D-0704-2022

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
48,907 tubes
Distribution
Nationwide in the USA and Puerto Rico
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teligent Pharma, Inc.. Units affected: 48,907 tubes.
Why was this product recalled?
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 30, 2022. Severity: Moderate. Recall number: D-0704-2022.