Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz S...
FDA Recall #D-0088-2018 — Class II — November 3, 2017
Product Description
Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08), 1 oz Spray (NDC 69804-015-07), 2 oz Spray (NDC 69804-015-01) and 4 oz Spray (NDC 69804-015-04) bottles, 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