FDA recall D-1278-2020

Wuhan Bingbing Pharmaceutical Co., Ltd. · Class II · drug

Product

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

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-1278-2020