The US Food and Drug Administration (FDA) announced that Solgar, Inc. is voluntarily recalling ABC Dophilus Powder. Testing conducted by the Centers for Disease Control revealed the presence of Rhizopus oryzae in 1.75 oz (50 g) containers of Solgar ABC Dophilus Powder, which may cause Mucormycosis. This is a rare infection that may cause health problems to consumers, particularly pre-mature infants/infants, children, and those with weakened immune systems. It may also occur rarely 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). 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.
Product recalled has lot number 074024-01R1, 074024-01, 074024-02; expiration date 7/31/15. This product was distributed to: AL, AR, AZ, CA, CT, CO, FL, IA, IL, IN, MI, ME, MO, MA, NC, NE, NY, NJ, NV, OH, OK, PA, PR, UT, TN, TX, VT, KY, WI, WA, UK and Israel through pharmacy, retail stores, wholesale, and the internet. The distribution of the product has been suspended while FDA and the company continue to investigate the source of the problem. Consumers who have purchased Solgar ABC Dophilus® Powder are urged not to consume the product. Susceptible consumers should consult with their physician or health care provider if they have used this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm423277.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Tuesday, November 18, 2014
Issued at HKT 13:00
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