Less than a month after a recall of their OTC artificial tear eye drops began, EzriCare LLC and Delsam Pharma LLC are targeted in litigation alleging harm from a bacterial contamination experts say has not previously been found in the US.
Litigation Follows OTC Eye Drops Recall Due To Bacteria Strain Not Previously Seen In US
Complaints Against EzriCare, Delsam, Aru Pharma Follow US Warning To Manufacturer In India
Following a recall earlier in February of EzriCare’s and Delsam’s OTC artificial tears due to potential bacterial contamination, plaintiffs’ bar steps in with first of what may be multiple lawsuits. CDC says drug-resistant strain of Pseudomonas aeruginosa bacteria not previously seen in US.
More from Legal
• By
It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.
• By
Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
• By
Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.
• By
Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.
More from Policy & Regulation
• By
“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
• By
“The president has chosen a do-it-all-now strategy, recognizing that the midterm congressional elections are a little over a year away,” says CHPA CEO Scott Melville. “We're just 57 days into the second Trump administration, and we are experiencing lots of unexpected things.”
• By
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.