FDA recall D-1277-2020

Product

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

Reason for recall

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2020-05-19

Report date

2020-06-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wuhan, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1277-2020