Global Pharma Healthcare is expanding the recall of eyedrops linked to a case of blindness and one death to include its eye ointment cream after recommendation by the U.S. Food and Drug Administration.
Global Pharma Healthcare issued a recall of a batch of its artificial eye ointment cream, distributed under the brand name Delsam Pharma, due to potential microbial contamination, the FDA announced.
Using the product could cause an eye infection that could lead to permanent blindness, according to the FDA recall.
'I want justice':: Woman who lost her eye to infection sues recalled eyedrop maker EzriCare
Previous recall linked to death, bacterial infection outbreak
The company said it had not received any reports so far of adverse reactions to the product.
But its recalled EzriCare Artificial Eye Drops were linked to a deadly multistate outbreak of a drug-resistant strain of Pseudomonas aeruginosa bacteria under investigation by the Centers for Disease Control and Prevention.
That outbreak of the rare strain has spanned twelve states, and swept up at least 55 patients, some of whom were believed to have used the recalled drops, according to an FDA announcement.
One person was hospitalized, one became permanently blind and another died after the infection reached their bloodstream.
All lots of the eyedrops were recalled.
Delsam Pharma Artificial Eye Ointment
The eye ointment cream batch under recall is Batch No. H29, the FDA said. It’s packaged in an aluminum tube inside a white carton, according to the FDA. The product is labeled with the following codes:
UPC: 3 72570 012235 3
The company asked consumers, wholesalers and retailers in possession of the product to discard it. The firm also asked any customer experiencing an adverse reaction to the ointment to contact their doctor and report it to the FDA.
The company said customers can contact the product’s distributor, Delsam Pharma, by calling 1-866-826-1306 or emailing email@example.com for further information.
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Contributing: Saleen Martin, USA TODAY
This article originally appeared on USA TODAY: Delsam Pharma eye ointment recalled over eye infection, blindness risk