Tag

Sterility

All articles tagged with #sterility

health2 hours ago•6 min saved

Millions of Rohto Eye Drops Recalled Over Sterility Concerns

Nearly 12 million Rohto Cooling Eye Drops cartons are being recalled nationwide due to a lack of assurance of sterility, a Class II FDA recall. The affected products were manufactured in Vietnam and distributed by The Mentholatum Company, covering eight Rohto variants with expiration dates from 2026 through 2029. Consumers should stop using recalled lots and may dispose of the drops or return them to the point of purchase for a full refund.

via NBC 5 Dallas-Fort Worth|

#eye-drops #fda #health

health3 years ago•3 min saved

FDA uncovers multiple issues at eye drop factory linked to deadly outbreak.

The FDA has found several manufacturing violations at Global Pharma's facility, including brown slime on filling equipment and a lack of basic measures to ensure sterility. The company's eye drops were linked to a deadly outbreak of extensively drug-resistant infections in the US, with 68 people infected and three deaths reported. The FDA had warned consumers to stop using the products, and Global Pharma later issued voluntary recalls. The inspection report outlines eleven "observations" of failures, with specifics, including a lack of validation data to demonstrate that the company's filtration system can "reliably sterilize" the eye drops.

via Ars Technica|

#eye-drops #fda #global-pharma