Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0087-2018·Announced 2017-11-29

FDA Recalls Extra Strength PreTAT Gel Due to Manufacturing Control Issues

Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel because of inadequate manufacturing control processes. The product was distributed throughout the United States.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level when no specific injuries or hospitalizations are reported in the source text. The hazard is related to manufacturing control rather than a specific acute physical danger like fire or choking.

Plain-English summary

Ridge Properties, LLC is recalling Extra Strength PreTAT by TAT BALM Gel, a lidocaine HCL 4% product, due to inadequate manufacturing control processes. The recall covers 1/2 oz, 1 oz, 2 oz, and 4 oz gel jars manufactured by Pain Relief Naturally. The product was distributed throughout the United States.

The recall is classified as FDA Class II. The source text indicates that the recall is due to Good Manufacturing Practice (GMP) deviations, specifically inadequate manufacturing control processes. All batches and lots with an expiration date of 10/17/2018 are affected, though not all batches were assigned lot numbers.

Consumers should stop using the product and contact the recalling firm for further instructions. The product is identified by NDC codes 69804-018-09, 69804-018-10, 69804-018-11, and 69804-018-12.

The recalled product

Product: 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
Manufacturer: Ridge Properties, LLC
Category: Drug — Topical Analgesic
Hazard: gmp-deviation
manufacturing-control

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Ridge Properties, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Ridge Properties, LLC

See all →

Severe
FDA Recalls Soothing Sore Relief Lidocaine Gel Due to Contamination
FDA (Drugs) · 2019-09-25
Severe
PRE-TAT Lidocaine Gel Recalled for Microbial Contamination
FDA (Drugs) · 2019-09-25
Severe
Soothing Sore Relief Lidocaine Cream Recalled for High Potency
FDA (Drugs) · 2019-09-25
Severe
Superior Pain & Itch Relief Cream Recalled for Lidocaine Contamination
FDA (Drugs) · 2019-09-25
Severe
PRE-TAT Lidocaine Cream Recalled for Microbial Contamination and Assay Failures
FDA (Drugs) · 2019-09-25

Same hazard · gmp deviation