USFDA Flags Major cGMP Deviations at Unexo Life Sciences: 15 Million Medicated Patches Recalled

New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch drug products in US following critical deviations flagged by USFDA in the manufacture of drug products. The recall include more than 12 Million patches of Absorbine Menthol backpatches and other medicated patches like Theracare Pain Relief patches, Lilas Feminine Pain Relief Patches, Equate Pain relief patches among others.

Earlier USFDA had inspected the Unexo facility (FEI 3013514280) at New Delhi in May 2024 and observed significant cGMP non compliances. The QC unit failed to have oversight over reliability of data and quality of finished drug products and failed to ensure compliance to cGMPs in the manufacture of the drug products. Critical deviations included significant data integrity issues with torn batch records, duplicate batch records and missing batch records which were observed piled up in plastic bags on the roof top. QC testing records for parameters like assay, patch weight, peel strength, rolling ball analysis lacked raw data. Control over computers were lacking with QC analyst able to manipulate results, dates and approval stamps in the computer. The computer having all cGMP data was allegedly taken home by QC analyst and could not be reached; and the QC Managers computer when finally presented to investigators all recent files and drives were deleted. Cleaning and maintenance of the manufacturing facility was also found to be inadequate with unclean air conditioner vents observed above production areas. Unexo was issued a Warning letter by USFDA in November 2024

Following the serious deficiencies FDA recommended the Firm to voluntarily recall all batches of drug products within expiry from the US market. The Firm also temporarily ceased manufacturing of products for US distribution.

• USFDA Warning Letter to Unexo (November 2024)
• Enforcement Reports Unexo Lifesciences (November 2024)