Approximately 27.8 million PAIN AID ESF (acetaminophen 250mg, aspirin 250mg, and caffeine 65mg) coated bulk tablets are being recalled due to manufacturing quality deviations. The manufacturer, ULTRAtab Laboratories, Inc., identified failed stability results and inadequate laboratory investigations, which means the medication may not maintain its intended strength or quality throughout its shelf life. These bulk tablets were distributed in 100 lb corrugated boxes to one customer who may have further distributed them.
Failed stability results mean the active ingredients like acetaminophen and aspirin may degrade faster than expected, potentially resulting in a product that is less effective or contains inconsistent dosages. While no injuries have been reported, using medication that does not meet quality standards can lead to inadequate treatment of pain or fever.
Contact healthcare provider and return product for 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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