Ridge Properties Recalls Bed Sore Cream Due to Manufacturing Control Issues
Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine due to inadequate manufacturing control processes.
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 and involves GMP deviations regarding manufacturing control processes without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ridge Properties, LLC is recalling Extra Strength Naturally HL Bed Sore Relief Cream with Added Lidocaine (lidocaine HCL 4%) in 1/2 oz, 1 oz, 2 oz, and 4 oz balm sizes. The recall is being conducted due to Good Manufacturing Practice (GMP) deviations, specifically inadequate manufacturing control processes.
The affected products include NDC 69804-008-06, 69804-008-05, 69804-008-02, and 69804-008-03. The recall covers all batches and lots with an expiration date of 10/17/2018. Not all batches were assigned lot numbers. The product was distributed throughout the United States.
Consumers should stop using the product and contact the manufacturer for further instructions.
The recalled product
- Product
- 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 69804-008-03), Manufactured by Pain Relief Naturally, www.Naturally HL.com
- Manufacturer
- Ridge Properties, LLC
- Category
- Drug — Topical Analgesic
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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