Granules USA, Inc. has recalled approximately 11.45 million Naproxen Sodium Tablets USP 220 mg (Caplets) because they were manufactured under conditions that deviated from Current Good Manufacturing Practice (CGMP) standards. While no specific injuries or adverse reactions have been reported to date, failure to follow these strict manufacturing protocols can affect the quality and consistency of the medication. These products were manufactured by Granules India Limited and distributed to wholesalers in New York.
Manufacturing deviations (CGMP deviations) mean the medication was not produced according to mandatory safety and quality standards, which can lead to variations in the drug's potency, purity, or effectiveness. This poses a potential health risk to consumers who rely on the medication for consistent pain relief.
Healthcare consultation and product refund
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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