Tag

Sterility

All articles tagged with #sterility

health22 hours ago•11 min saved

FDA classifies 750,000-unit eye drop recall as Class II over sterility concerns

The U.S. Food and Drug Administration has classified a voluntary recall of nearly 750,000 units of eye drops and ointments as Class II, citing a lack of assurance of sterility. Initiated by Sterling Pharmaceutical Services LLC in August 2026, the recall affects nine products sold under brands including Walgreens, AvKare, and Reliable-1. Consumers are advised to check lot numbers and expiration dates against FDA records and discontinue use if their products are affected.

via USA Today|

#consumer-safety #eye-drops #fda-recall

healthcare1 month ago•3 min saved

Nationwide Epinephrine Recall Tied to Sterility and Particulate Contamination

The FDA announced a nationwide recall of three Epinephrine Injection, USP 30 mg/30 mL multi-dose vials by American Regent due to sterility concerns and particulate contamination (nylon, cellulosic, acrylic, polyethylene, glass). Specific lots 25128L1C0 (Exp Aug 2026), 25280L1C0 (Exp Oct 2026), and 26108L1C0 (Exp July 2027) were distributed nationwide. Patients should stop using recalled product and contact their healthcare provider; distributors and customers will be notified for return or replacement. No adverse events have been reported yet; contact information for questions is provided by American Regent.

via WESH|

#american-regent #epinephrine #healthcare

health1 month ago•1 min saved

Nearly 40,000 eye drops recalled over sterility concerns

The FDA-classified Class II recall covers 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops (lot 2552A, exp. 2027-09-30) distributed by Medtech Products Inc. The 15ml bottles, sold at major retailers, are being pulled due to lack of assurance of sterility; consumers should stop using them and return for refunds, and seek care if any issues arise. This recall follows prior eye-drop safety issues, such as the EzriCare outbreak in 2023.

via The Guardian|

#eye-drops #fda #health

health1 month ago•385 min saved

Nationwide recall of Clear Eyes eye drops due to sterility concerns, FDA says

Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops distributed nationwide have been voluntarily recalled by Medtech Products (owned by Prestige Consumer Healthcare) after the FDA flagged a lack of assurance of sterility; 39,060 units are affected (Lot 2552A, D-0766-2026, exp. 9/30/2027); no injuries have been reported; recall began July 29, 2026 and is ongoing; products were sold over the counter at retailers such as CVS and Walmart.

via NBC News|

#contamination #eye-drops #fda

health2 months 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