FDA Recalls Naturally HL Hemorrhoid Balm for Manufacturing Control Issues
Ridge Properties, LLC is recalling Naturally HL Hemorrhoid Numbing Balm due to inadequate manufacturing control processes. The product was distributed throughout the United States.
What this means for you
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 indicates a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text cites GMP deviations without reporting specific injuries or illnesses, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Ridge Properties, LLC is recalling 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). The recall is being conducted because of Good Manufacturing Practice (GMP) deviations, specifically inadequate manufacturing control processes.
The affected product was distributed throughout the United States. The recall covers all batches and lots with an expiration date of 10/17/2018. Not all batches were assigned lot numbers.
Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- 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 HL.com
- Manufacturer
- Ridge Properties, LLC
- Category
- Drug — Topical Anesthetic
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.
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