Solgar, Inc., of Leonia, NJ, recalled ABC Dophilus Powder because this probiotic was found to contain Rhizopus oryzae, which may cause Mucormycosis. Mucormycosis is a rare fungal infection that may cause life-threatening health problems to consumers, particularly premature infants, infants, children, and those with weakened immune systems. However, it may also occur in people who are otherwise healthy.
Risk factors for developing Mucormycosis include: uncontrolled diabetes; cancer; organ transplant; neutropenia (low white blood cells); skin trauma (cuts, scrapes, punctures, or burns). This serious fungal infection targets the sinuses, brain, GI tract or lungs. Surviving Mucormycosis requires rapid diagnosis and aggressive medical and surgical therapy.
ABC Dophilus was used as part of the in-hospital course of treatment for a very preterm infant (<32 week gestation) who suffered from multiple complications, including intestinal Mucormycosis, and died on October 11, 2014. Testing conducted by the CDC revealed the presence of Rhizopus oryzae in 1.75 oz. (50 g) containers of Solgar ABC Dophilus Powder-- Lot# 074024-01R1, 074024-01, 074024-02-- Expiration Date 7/31/15.
This product was distributed to Alabama, Arizona, Arkansas, California, Connecticut, Colorado, Florida, Iowa, Illinois, Indiana, Michigan, Maine, Missouri, Massachusetts, North Carolina, Nebraska, New York, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, Utah, Tennessee, Texas, Vermont, Kentucky, Wisconsin, Washington, Puerto Rico, the United Kingdom, and Israel through pharmacy, retail stores, wholesale, and the internet. The distribution of the product has been suspended while the FDA and the company continue to investigate the source of the problem.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, April 2013 Report: Complementary and Alternative Medicine: Practitioner Liability
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication