FDA recall D-0087-2018

Ridge Properties, LLC · Class II · drug

Product

Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Reason for recall

GMP Deviations: inadequate manufacturing control processes

Distribution

Product distributed throughout United States.

Key facts

Status: Terminated
Initiation date: 2017-11-03
Report date: 2017-11-29
Termination date: 2019-01-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salem, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0087-2018