The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0088-2018·Announced 2017-11-29

FDA Recalls Naturally HL Hemorrhoid Spray for Manufacturing Control Issues

Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Spray due to 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, and the source text cites GMP deviations without reporting specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ridge Properties, LLC is recalling Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine (lidocaine HCL 4%) in 1/2 oz, 1 oz, 2 oz, and 4 oz spray bottles. The recall is being conducted because of Good Manufacturing Practice (GMP) deviations, specifically inadequate manufacturing control processes.

The affected products include NDC 69804-015-08, NDC 69804-015-07, NDC 69804-015-01, and NDC 69804-015-04. All batches and lots with an expiration date of 10/17/2018 are affected, though not all batches were assigned lot numbers. The product was distributed throughout the United States.

Consumers should stop using the product and contact the recalling firm for further instructions or a refund.

The recalled product

Product
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…
Manufacturer
Ridge Properties, LLC
Category
Drug — Topical Anesthetic
Hazard

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 →

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