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The FDA has issued a significant recall affecting 15 million over-the-counter pain relief patches manufactured by Unexo Life Sciences in New Delhi, India. The recall stems from the facility’s non-compliance with Current Good Manufacturing Practice (cGMP) regulations, potentially compromising product safety and quality. The affected patches contain various active ingredients including lidocaine, camphor, and menthol, and were distributed throughout the United States.
Key Points:
- The FDA identified multiple compliance violations at Unexo’s New Delhi facility, including inadequate quality assurance processes, documentation deficiencies, improper testing protocols, insufficient computer system controls, and substandard equipment sanitization procedures.
- Eleven specific products are affected by the recall, including popular brands such as Absorbine Jr., Theracare, HealthWise, Equate, and others, with individual product quantities ranging from 10,000 to 7 million units.
- Alternative OTC options remain available, including Icy Hot Max (lidocaine 4% / menthol 1%), Salonpas Pain Relieving Gel-Patch (lidocaine 4%), and prescription alternatives such as Lidoderm (lidocaine 5%) and ZTlido (lidocaine 1.8%).
- Healthcare providers should advise patients to discontinue use of recalled patches immediately, regardless of previous successful outcomes, and report any adverse effects to the FDA.
- The recall impacts specific UPC codes, with the largest quantities affecting Absorbine Jr. products (approximately 13 million units total across their product line).
HCN Medical Memo
This extensive recall necessitates immediate patient education regarding discontinued use of affected products and guidance toward FDA-compliant alternatives. Consider this an opportunity to review pain management strategies with affected patients and ensure they understand both OTC and prescription options available to them.
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