Drug & medication recalls Moderate risk

Ridge Properties, LLC recalls Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm(NDC 69804-008-0…

Recall date
November 3, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0086-2018
FDA classification
Class II
Brand / firm
Ridge Properties, LLC
Sold / distributed
Product distributed throughout United States.

Why it was recalled

GMP Deviations: inadequate manufacturing control processes

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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