Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Re

FDA recall notice · announced November 29, 2017 · Ridge Properties

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid Gel (NDC 69804-024-16) bottles, Manufactured by Pain Relief Naturally, www.Naturally HL.com

Reason for recall

GMP Deviations: inadequate manufacturing control processes

Notes

Distribution: Product distributed throughout United States.
Lot/code information: All batches and lots, exp 10/17/2018. Not all batches were assigned lot numbers
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 (D-0086-2018)
- Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2 oz Balm(NDC 69804-014-03), Manufactured by Pain Relief Naturally, www.Naturally (D-0090-2018)
- Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) , 2 oz Gel (NDC 69804-018-11), and 4 oz Gel (NDC 69804-018-12) jars, Manufactured (D-0087-2018)
- 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 (N (D-0088-2018)
- Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 oz Liquid Gel (NDC 69804-024-14), 2 oz Liquid Gel (NDC 69804-024-15), 4 oz Liquid (D-0089-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.