Food Safety and Standards Authority of India has published a document about the product Solgar ABC Dophilus® Powder after an alert from INFOSAN which stated that the product has been recalled due to contamination with Rhizopus oryzae-reg. The product is a probiotic health supplement for infants and children. Through this document, FSSAI wishes to bring information about the recall to the notice of the stakeholders and the public.
The US FDA announced on 19th November, 2014 that the company Solgar Inc. had issued a recall of ABC Dophilus Powder as it was found to contain Rhizopus oryzae-reg, a fungus that may cause Mucormycosis. Mucormycosis is a rare infection that may cause health problems to consumers particularly to pre-mature infants, infants, children and those with weakened immune systems. It may also occur though rarely in people who are otherwise healthy. Risk factors for developing Mucormycosis include uncontrolled diabetes, cancer, organ transplant, neutropenia (low white blood cell count) skin trauma (cuts scrapes, punctures or burns).
ABC Dophilus ® Powder sold by Solgar Inc. Leonia New Jersey was used as part of the in-hospital course of treatment for a pre-term baby who died on 11 October, 2014 in the USA. Gastrointestinal tissues from the infant underwent laboratory testing at US CDC which revealed invasive Mucormycosis due to the mould Rhizopus oryzae-reg. Tests conducted by the local medical facility in the United States revealed the presence of mould in unopened 1.75oz (50g) containers of Solgar ABC Dophilus® Powder This mould was later confirmed by US CGD as Rhizopus oryzae-reg. US CDG provided this information to the US FDA on 12 November, 2014.
On November 17, 2014 Solgar Inc. of Leonia NJ in a press release stated that they are voluntarily recalling ABC Dophilus® Powder as a cautionary measure because the product was found to contain Rhizopus oryzae which may cause Mucormycosis and named the countries the product is sold in including India. This product is widely distributed across the USA and the United Kingdom and Israel. In addition the product was available for purchase via internet. Details regarding which countries could have received the recalled the product via internet is pending.
The distribution of the product has been suspended while US FDA and the company continue to investigate the source of the problem. In India, the product has been distributed through pharmacies, retail stores, wholesale outlets and online via internet. FSSAI says that since the product has been sold in India, it is important to report the cases of infection if any and suspend the consumption of the supplement for infants and children immediately.
The Recall product details are as follows.
- Description Solgar ABC Dophilus® Powder NET Wt.1.75oz (50g)
- UPC code 0 33984 00010 0
- Label: Solgar
- Lot# 074024-01R1, 074024 -01 074024 -02
- Expiration date 7/31/15
Through the press release Solgar Inc. have asked people who have purchased the recalled product not consume it or give it to their infants. They should consult with a physician or health care provider if they have consumed it. To date the INFOSAN Secretariat has not been informed of additional cases of illness linked to this product outside of the USA.
If any cases of Mucormycosis are found to be linked to the supplement Solgar ABC Dophilus® Powder (which has a long shelf life), worldwide consumers have been asked to contact national IHR Focal Point. They must also inform to INFOSAN Secretariat so that the international aspect can be summarized.
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