DuPont Nutrition USA, Inc. has recalled approximately 80 kilograms (about 176 pounds) of Avicel RC-591 NF, a bulk powder used as a component in various drug formulations. The recall was initiated after testing revealed that the product exceeded acceptable limits for total aerobic microbial count (TAMC), meaning it contains higher than allowed levels of bacteria. This bulk ingredient was distributed to a single account and may have been further incorporated into finished medications distributed nationwide across the United States.
Using products contaminated with high levels of aerobic microbes can lead to infections, particularly in individuals with weakened immune systems or when used in certain medical applications. While no specific injuries or illnesses have been reported for this lot, the presence of microorganisms above safety specifications poses a potential health risk to consumers who use medications manufactured with this component.
Manufacturer initiated recall via notification letter.
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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