FDA recall D-0086-2018

Ridge Properties, LLC · Class II · drug

Product

Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-06), 1 oz Balm (NDC 69804-008-05), 2 oz Balm(NDC 69804-008-02), and 4 oz Balm(NDC 69804-008-03), 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-0086-2018