FDA Drug Class II — Moderate

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

Hazard

GMP Deviations: inadequate manufacturing control processes

Products

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
Brand
Ridge Properties, LLC
UPC
All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Units Affected

N/A