Novel Laboratories, Inc. (d.b.a LUPIN) is recalling 20,814 bottles of GaviLyte-C (PEG-3350 and Electrolytes for Oral Solution, USP) with Flavor Pack. This medication, used for bowel cleansing before colonoscopies, was found to be out of specification for osmolarity during stability testing. Consumers who have this specific medication should contact their doctor or pharmacist to discuss alternatives, as the product may not perform as intended.
The product failed stability tests for osmolarity, meaning the concentration of particles in the solution is incorrect. This imbalance can potentially affect the safety and effectiveness of the bowel preparation process, though no specific injuries have been reported to date.
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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