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Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine, (lidocaine HCL 4%), 1/2 o...

FDA Recall #D-0086-2018 — Class II — November 3, 2017

Recall #D-0086-2018 Date: November 3, 2017 Classification: Class II Status: Terminated

Product Description

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

Recalling Firm

Ridge Properties, LLC — Salem, OR

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

Product distributed throughout United States.

Code Information

All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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