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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Solgar, INC. Issues Voluntary Class I Recall Of ABC Dophilus® Powder

Contact:
Consumer:
1-800-332-1088

FOR IMMEDIATE RELEASE — November 17, 2014 — Solgar, Inc., of Leonia, NJ, is voluntarily recalling ABC Dophilus® Powder. The recall was initiated, out of an abundance of caution, because the product was found to contain Rhizopus oryzae, 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. Although, it may also occur (rarely) in people who are otherwise healthy. 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. Susceptible consumers should consult with their physician or health care provider if they have used this product.

Solgar is notifying consumers and customers not to consume this product

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, internet, etc.

Description: Solgar ABC Dophilus® Powder NET Wt. 1.75 oz (50 g)
UPC Code: 0 33984 00010 0
Label: Solgar
Lot# 074024-01R1, 074024-01, 074024-02 Expiration
Date 7/31/15

Testing conducted by the Centers for Disease Control revealed the presence of Rhizopus oryzae in 1.75 oz (50 g) containers of Solgar ABC Dophilis Powder.

The distribution of the product has been suspended while FDA and the company continue to investigate the source of the problem.

Risk factors for developing Mucormycosis include: uncontrolled diabetes; cancer; organ transplant; neutropenia (low white blood cells); skin trauma (cuts, scrapes, punctures, or burns). Susceptible consumers should consult with their physician or health care provider.

Consumers who have purchased Solgar ABC Dophilus® Powder are urged not to consume the product and should return it to the place of purchase for a full refund. Consumers with questions may contact the company at 888-534-6370, Monday-Friday, 9AM-7PM ET.

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

 

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Page Last Updated: 11/17/2014
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