ABC Dophilus Powder by Solgar, Inc: Recall – Risk of Infection

This is a reprint of an FDA Alert.

[Posted 11/17/2014]

AUDIENCE: Consumer, Pediatrics, Emergency Medicine, Family Practice

ISSUE: 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).

Product recalled has UPC Code: 0 33984 00010 0; Lot# 074024-01R1, 074024-01, 074024-02; Expiration Date 7/31/15

BACKGROUND: 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.

RECOMMENDATION: Do not consume this product. Susceptible consumers should consult with their physician or health care provider if they have used this product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[11/14/2014 – Press Release – Solgar, Inc]