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“ - 1 weren't - 1
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U.S India Kilitch Healthcare India Mumbai Farmingdale N.Y India’s Tamil Nadu
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CVS Health - 3 Target - 3 FDA - 3 Cardinal Health - 3 Delsam Pharma - 3 Centers for Disease Control - 3 WASHINGTON - 2 Associated Press Health - 2

Search resuls for: "Delsam Pharma"


5 mentions found


☆ Indian Manufacturer Recalls Eyedrops Previously Cited in FDA Warning
  + stars: | 2023-11-16 | by ( Associated Press | Nov. | At P.M. | ) www.usnews.com   time to read: +3 min
FDA officials don't have the legal authority to force manufacturers to recall their products, and instead rely on companies to “voluntarily” do so. The FDA previously stated it recommended the manufacturer recall the eyedrops on Oct. 25. That suggests agency officials may still be finalizing documentation from the inspection that triggered the latest recall. Agency records show FDA didn't conduct any inspections in India during fiscal year 2021, at the height of the pandemic. CVS Health said in a statement that it previously “stopped the sale in-store and online” of all the eyedrops cited by the FDA.
Persons: “, weren't Organizations: WASHINGTON, CVS Health, Target, Rite, Kilitch Healthcare, Food and Drug Administration, FDA, Healthcare, U.S, Velocity Pharma, Agency, COVID, CVS, Cardinal Health, Delsam Pharma, Centers for Disease Control, CDC, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: U.S, Kilitch Healthcare India, Mumbai, Farmingdale, N.Y, India, India’s, Tamil Nadu
☆ Eyedrops from CVS, Rite Aid and others carry possible infection risk, FDA says
  + stars: | 2023-10-30 | by ( ) www.cnbc.com   time to read: +1 min
U.S. health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness. The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health , Target , Rite Aid and Cardinal Health . The agency asked the companies to recall their products last week, because FDA inspectors found unsanitary conditions and bacteria at the facility producing the drops. Earlier this year, federal officials linked an outbreak of drug-resistant bacteria to eyedrops from two companies, EzriCare and Delsam Pharma. After the products were recalled in February, health inspectors visited the manufacturing plant in India that made the eyedrops and uncovered problems with how they were made and tested, including inadequate sterility measures.
Organizations: U.S . Food, Drug Administration, Drug, CVS Health, Target, Rite Aid, Cardinal Health, Consumers, FDA, Delsam Pharma, Centers for Disease Control Locations: U.S, White Oak , Maryland, India
☆ Eyedrops From CVS, Rite Aid and Others Carry Possible Infection Risk, FDA Says
  + stars: | 2023-10-30 | by ( Associated Press | Oct. | At A.M. | ) www.usnews.com   time to read: +1 min
The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health, Target, Rite Aid and Cardinal Health. Consumers should stop using the products immediately and avoid purchasing any that remain on pharmacy and store shelves, the FDA said in a statement Friday. The agency asked the companies to recall their products last week, because FDA inspectors found unsanitary conditions and bacteria at the facility producing the drops. Earlier this year, federal officials linked an outbreak of drug-resistant bacteria to eyedrops from two companies, EzriCare and Delsam Pharma. ___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group.
Organizations: WASHINGTON, —, Drug, CVS Health, Target, Rite Aid, Cardinal Health, Consumers, FDA, Delsam Pharma, Centers for Disease Control, Associated Press Health, Science Department, Howard Hughes Medical Institute’s Science, Educational Media Group, AP Locations: — U.S, U.S, India
☆ Over-the-counter eye drop has been linked to infections leading to eyeball removal, vision loss, and one death: CDC
  + stars: | 2023-03-19 | by ( Aidan Pollard | ) www.businessinsider.com   time to read: +2 min
EzriCare eye drops were recalled in February over possible bacterial contamination. The CDC recommends avoiding EzriCare and Delsam Pharma Artificial Tears. EzriCare Artificial Tears, an over-the-counter eye drop made by Global Pharma Healthcare, was recalled in early February, NBC News reported. According to the CDC, most patients reported using eye drops — and many reported using EzriCare specifically. EzriCare and Delsam Pharma drops were distributed across the US over the internet, according to Global Pharma Healthcare.
☆ U.S. FDA says India-made eye drop linked to some infections, blindness and one death
  + stars: | 2023-02-03 | by ( ) www.reuters.com   time to read: +2 min
The agency said on Thursday that Artificial Tears eye drop manufactured by India's Global Pharma Healthcare Pvt Ltd has a potential bacterial contamination and the company has violated current good manufacturing practices. Global Pharma Healthcare did not immediately respond to a Reuters request seeking comment on the FDA statement. EzriCare said in a statement on Wednesday that it had stopped further distribution and sale of the eye drop, and it was not aware of any testing that "definitively links" the bacterial outbreak to the product. It said that as of Jan. 31, the CDC had identified 55 patients in 12 states with infections linked to the use of Artificial Tears distributed by EzriCare, it said. "Associated adverse events include hospitalization, one death with bloodstream infection, and permanent vision loss from eye infections," the FDA said.
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