PlainRecalls
FDA Drug Moderate Class II Terminated

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 by Pain Relief Naturally, www.Naturally HL.com

Reported: November 29, 2017 Initiated: November 3, 2017 #D-0087-2018

Product Description

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 by Pain Relief Naturally, www.Naturally HL.com

Reason for Recall

GMP Deviations: inadequate manufacturing control processes

Details

Recalling Firm
Ridge Properties, LLC
Units Affected
N/A
Distribution
Product distributed throughout United States.
Location
Salem, OR

Frequently Asked Questions

What product was recalled?
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 by Pain Relief Naturally, www.Naturally HL.com. Recalled by Ridge Properties, LLC. Units affected: N/A.
Why was this product recalled?
GMP Deviations: inadequate manufacturing control processes
Which agency issued this recall?
This recall was issued by the FDA Drug on November 29, 2017. Severity: Moderate. Recall number: D-0087-2018.