Our lawyers investigate fungal and other infections caused by dietary supplements called probiotics. These dietary supplements have live bacteria and/or yeast in them. In many cases, patients with fungal infections do not know the source of the infection.
Dietary supplements containing live bacteria or yeast can cause fungal infections in premature babies and people with compromised immune systems (cancer, HIV, diabetes, etc.), acknowledges the FDA.
In a safety alert issued today, the FDA warned health care professionals that dietary supplements containing live bacteria or yeast may cause severe illness, including fungal infections.
ABC Dophilus Powder Linked to Wrongful Death of Newborn
In the safety alert, the FDA points to a case were a premature infant administered a dietary supplement (ABC Dophilus Powder, made by Solgar) developed gastrointestinal mucormycosis from the mold Rhizopus oryzae and died. The CDC found Rhizopus oryzae mold in an unopened container of the ABC Dophilus Powder. This is solid evidence that this product sickened the baby.
FDA, along with the Centers for Disease Control and Prevention (CDC) and the Connecticut Department of Public Health, are investigating the death of this little one.
Our lawyers recently settled a case similar to this one where newborn babies were sickened by another medical product that caused serious infections. Some of our cases were, like this one, wrongful death cases.
Parents, you and your little ones have legal rights. You can click here now or call 1-888-3;77-8900 (toll free) to contact our law firm and get help.
ABC Dophilus Powder Recall
In mid-November, Solgar issued a recall for certain lots of ABC Dophilus Powder and public health warnings were issued advising customers and consumers not to use the recalled product.
Product Recalled: Solgar ABC Dophilus® Powder NET Wt. 1.75 oz (50 g)
UPC Code: 0 33984 00010 0
Lot Numbers: Lot# 074024-01R1, 074024-01, 074024-02
Expiration Date: 7/31/15
The product was distributed to: Alabama AL, Arkansas AR, Arizona AZ, California CA, Connecticut CT, Colorado CO, Florida FL, Iowa IA, Illinois IL, Indiana IN, Michigan MI, Maine ME, Montana MO, Massachusetts MA, North Carolina NC, Nebraska NE, New York NY, New Jersey NJ, Nevada NV, Ohio OH, Oklahoma OK, Pennsylvania PA, Puerto Rico PR, Utah UT, Tennessee TN, Texas TX, Vermont VT, Kentucky KY, Wisconsin WI, Washington WA, UK and Israel through pharmacy, retail stores, wholesale, and the internet.
Dietary supplements, including probiotics, are generally not regulated as drugs by the FDA. This means they are not subject to FDA’s:
- premarket review;
- approval requirements for safety and effectiveness;
- rigorous manufacturing and testing standards for drugs, including testing for extraneous organisms.
FDA Recommendation for Doctors and Hospitals
FDA is advising doctors, nurse practitioners and hospitals to approach the use of probiotics with caution. FDA encourages health care providers who use dietary supplements containing live bacteria or yeast as drugs (e.g., to treat, mitigate, cure, or prevent a disease or condition) to submit an Investigational New Drug Application (IND) for FDA review.