Three lots of the probiotic ABC Dophilus were recalled in Nov. 2014 when a premature baby died after being given the supplement in a hospital. The Centers for Disease Control and Prevention (CDC) determined that the recalled lots contained Rhizopus oryzae, a fungus that can cause a severe infection of the sinus, lungs, intestines and skin called mucormycosis.
Free Solgar ABC Dophilus Lawsuit Evaluation: If your child or other loved one was injured after being given ABC Dophilus probiotic supplements, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against Solgar, Inc. and we can help.
What is ABC Dophilus?
ABC Dophilus Powder is a probiotic blend of bacteria specially formulated to maintain digestive health in children and infants. The supplement can be purchased over the counter for use at home, and is also used in some hospitals. Medical studies have found that probiotics may prevent necrotizing enterocolitis (NEC), an inflammation and necrosis (death of tissue) of the bowel. ABC Dophilus Powder is manufactured by Solgar Inc. of Leonia, New Jersey.
ABC Dophilus Recall Issued After Baby Dies
On Nov. 17, 2014, the U.S. Food & Drug Administration (FDA) announced a nationwide recall for 3 lots of ABC Dophilus Powder after it was found to contain Rhizopus oryzae, a fungus that can cause mucormycosis, a rare infection typically found in infants, children and patients with compromised immune systems.
ABC Dophilus was used as part of the in-hospital treatment course for a preterm infant who died after being given the product. The baby suffered from multiple complications, including intestinal mucormycosis, and died on Oct. 11, 2014. CDC investigators later found Rhizopus oryzae fungus in containers of ABC Dophilus with the same lot number as the product given to the deceased infant.
Which Products are Affected?
- Product Recalled: Solgar ABC Dophilus® Powder NET Wt. 1.75 oz (50 g)
- UPC Code: 0 33984 00010 0
- Label: Solgar
- Lot Numbers: Lot# 074024-01R1, 074024-01, 074024-02
- Expiration Date: 7/31/15
ABC Dophilus products affected by this recall were distributed to Alabama, Arkansas, Arizona, California, Connecticut, Colorado, Florida, Iowa, Illinois, Indiana, Michigan, Maine, Montana, Massachusetts, North Carolina, Nebraska, New York, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Utah, Tennessee, Texas, Vermont, Kentucky, Wisconsin and Washington.
Rhizopus oryzae is a common fungus found in decaying organic matter like leaves and rotting wood. An outbreak of mucormycosis of the skin caused by rhizopus oryzae occurred during the cleanup of the Joplin, Missouri tornado in 2011. According to a Solgar spokesperson, because the fungus is so ubiquitous, “the exact source of where this mold came from is extremely difficult to determine.” ABC Dophilus is made for Solgar by a contract manufacturer, but the company declined to name its supplier.
Should Probiotics be Used to Treat Premature Infants?
FDA classifies probiotic supplements as foods, not drugs. ABC Dophilus’ labeling states that it contains bacterial species that “support good health in these populations [infants and children] by helping to maintain a healthy balance within the intestine’s microbial ecology.” However, this claim is immediately followed by an asterisk which refers to the small print phrase “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”
Despite conflicting clinical trials and lack of FDA approval, probiotic supplements like ABC Dophilus have been increasingly used in neonatal intensive care units (NICUs) to prevent necrotizing enterocolitis (NEC), a disease of premature infants where the intestinal wall becomes inflamed and bacteria invade the bowel wall.
Do I Have a Solgar ABC Dophilus Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Solgar ABC Dophilus Lawsuits. We are handling individual litigation nationwide and currently accepting new fungal infection cases in all 50 states.
Free Solgar ABC Dophilus Lawsuit Evaluation: Again, if your child or other loved one was injured after being given ABC Dophilus Powder, you should contact our law firm immediately. You may be entitled to compensation by filing an ABC Dophilus suit and we can help.