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Clear Eyes Eye Drops Recalled Nationwide Due to Contamination Risk

Clear Eyes Eye Drops Recalled Nationwide Due to Contamination Risk

Prestige Consumer Healthcare, a New York-based company, has initiated a nationwide recall of nearly 40,000 bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops. The recall, which began on July 29, is due to a "lack of assurance of sterility" and potential contamination, according to a notice from the U.S. Food and Drug Administration (FDA). The affected product is the 15mL bottle of Clear Eyes' Maximum Itchy Eye Relief, which is marketed to alleviate itchiness, redness, and other eye irritations. The FDA has classified this as a Class II recall, indicating that exposure to the contaminated product could lead to "temporary or medically reversible adverse health consequences." Prestige Consumer Healthcare has not yet provided a public response regarding the recall.

FDA Issues Class II Recall for Clear Eyes Maximum Itchy Eye Relief Drops

FDA Issues Class II Recall for Clear Eyes Maximum Itchy Eye Relief Drops

The U.S. Food and Drug Administration (FDA) has upgraded a recall for nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief drops to a Class II classification. This recall, initiated by Prestige Brand Holdings, affects 15 mL bottles with an expiration date of September 30, 2027. The specific lot code is 2552A, NDC 67172-999-01, and UPC 6 78112 65920 3. The reason for the recall is a 'lack of assurance of sterility,' meaning the eye drops could potentially be contaminated with bacteria or fungi. While the FDA states that medical problems resulting from exposure would likely be temporary and treatable, consumers are advised to stop using the product immediately. The affected eye drops were distributed nationwide and sold at major retailers including Amazon, CVS, Kroger, Walgreens, Target, Menards, and Dollar General.

Prestige Brand Holdings Recalls 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns

Prestige Brand Holdings has voluntarily recalled nearly 40,000 bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops nationwide, including in Rhode Island. The U.S. Food and Drug Administration (FDA) reported that the recall is due to a "lack of assurance of sterility." The affected products are 15mL bottles with an expiration date of September 30, 2027. The FDA has classified this as a Class II recall, indicating that the use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Consumers are advised not to use the recalled eye drops as they could be contaminated or cause infection. Prestige Brand Holdings, a consumer healthcare company known for products like Dramamine and Breathe Right, has not yet responded to requests for comment.

FDA Recalls Nearly 40,000 Bottles of Clear Eyes Eye Drops Due to Sterility Concerns

FDA Recalls Nearly 40,000 Bottles of Clear Eyes Eye Drops Due to Sterility Concerns

The U.S. Food and Drug Administration (FDA) has issued a recall for approximately 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief. This nationwide recall, initiated by Prestige Consumer Healthcare, stems from a lack of assurance of sterility in the product. The affected eye drops are 15-milliliter bottles with an expiration date of September 30, 2027. These over-the-counter eye drops are widely available at various pharmacies and retailers across the U.S., including CVS, Walgreens, Amazon, Walmart, Dollar General, and Target. Consumers who have purchased the recalled product are advised to immediately cease use and return the eye drops to the place of purchase for a refund.

Nearly 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Recalled Due to Sterility Concerns

Nearly 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Recalled Due to Sterility Concerns

Approximately 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops have been recalled by the manufacturer due to concerns regarding potential contamination and a lack of assurance of sterility. The Food and Drug Administration (FDA) initiated this recall, specifically targeting 0.5-fluid-ounce bottles from lot 2552A, which have an expiration date of September 30, 2027. The FDA has classified this as a Class II recall, indicating that while the use of the product may lead to temporary or medically reversible adverse health consequences, the likelihood of serious health consequences is considered remote. Consumers who possess the recalled eye drops are advised to discontinue use immediately and dispose of the product. Information regarding potential refunds can be obtained from the place of purchase.

U.S. Lawmakers Urge FDA to Tighten Regulations on Chinese Clinical Trial Data Following Patient Deaths

U.S. Lawmakers Urge FDA to Tighten Regulations on Chinese Clinical Trial Data Following Patient Deaths

Two Republican U.S. Representatives, John Moolenaar of Michigan and Ben Cline of Virginia, have sent a letter to the acting commissioner of the U.S. Food and Drug Administration (FDA), Kyle Diamantas, demanding stricter regulations on the use of Chinese clinical trial data in U.S. drug development and approval processes. This demand follows recent reports of three patient deaths in China involving experimental gene therapies, including two children. The lawmakers highlighted concerns that the U.S. is accepting unverified Chinese clinical data, potentially exposing patients to undue risks. They specifically requested that the FDA not accept clinical trial data generated in China for Investigational New Drug (IND) applications, New Drug Applications (NDA), or Biologics License Applications (BLA), unless the trial sites have undergone an FDA on-site inspection within 12 months prior to the application submission. Additionally, they called for a comprehensive evaluation of the U.S. reliance on Chinese-initiate...

Prestige Brand Holdings Recalls Nearly 40,000 Bottles of Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns

Prestige Brand Holdings has initiated a voluntary nationwide recall of approximately 39,060 bottles of its Clear Eyes Maximum Itchy Eye Relief eye drops. The U.S. Food and Drug Administration (FDA) announced this action, classifying it as a Class II recall. The primary reason for the recall is a "lack of assurance of sterility," which raises concerns about potential contamination. The affected products are 15mL bottles with an expiration date of September 30, 2027. Consumers are advised against using these recalled eye drops due to the risk of contamination or infection. Prestige Brand Holdings is a consumer healthcare company known for various over-the-counter products, including Dramamine and Monistat. The company has not yet publicly commented on the recall.

Nearly 40,000 bottles of eye drops recalled. See the affected product

Nearly 40,000 bottles of eye drops recalled. See the affected product

Nearly 40,000 bottles of eye drops are being recalled due to a possible contamination problem.

Outshine Frozen Fruit Bars Recalled Nationwide Due to Glass Contamination

Outshine Frozen Fruit Bars Recalled Nationwide Due to Glass Contamination

Dreyer’s Grand Ice Cream Inc. has issued a nationwide recall for specific batches of Outshine Fruit Bars due to potential contamination with glass. The recall affects 6-count, 2.5-ounce packages of strawberry, watermelon, grape, black cherry, and tangerine fruit bars, as well as 24-count, 2.5-ounce packages of variety pack fruit bars. The U.S. Food and Drug Administration (FDA) has been notified, and the products were distributed to retailers across the country, including major stores like Times/Don Quijote, KTA Super Stores, Walmart, and Target in Hawaii. The Hawaii Department of Health's food and drug branch is actively working with local retailers to ensure that all recalled products are removed from sale. Dreyer’s initiated the recall as a precautionary measure following consumer reports of glass fragments found in the fruit bars, though no injuries or illnesses have been reported to date.

B. Braun Medical Inc. Recalls Excel® Lactated Ringers Injection Due to Particulate Matter

B. Braun Medical Inc. Recalls Excel® Lactated Ringers Injection Due to Particulate Matter

B. Braun Medical Inc. has initiated a voluntary North American recall of one lot of its Excel® Lactated Ringers Injection, 1000mL, distributed to hospitals and healthcare facilities. The recall is due to the presence of particulate matter in the solution, primarily identified as cellulose cotton fibers, with some particles also being cellulose wood fiber and polystyrene. The affected product, with lot number J4H077 and an expiration date of November 30, 2026, was distributed nationwide in the U.S. and to Canada between August 29, 2024, and September 30, 2024. The product is used for hydration and fluid replacement in adult, pediatric, and neonatal patients. B. Braun has not received any reports of adverse events related to this recall to date. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Trump picks White House ally Overton to lead embattled FDA

Trump picks White House ally Overton to lead embattled FDA

By Yasmeen Abutaleb WASHINGTON, Aug 19 (Reuters) - U.S.

President Trump Selects Heidi Overton to Lead FDA Amid Staff Departures and Political Scrutiny

President Trump Selects Heidi Overton to Lead FDA Amid Staff Departures and Political Scrutiny

President Trump has chosen White House policy aide Heidi Overton to serve as the next commissioner of the Food and Drug Administration (FDA), according to a source familiar with the matter. This selection comes months after the previous chief, Marty Makary, resigned. If confirmed by the Senate, Overton will take charge of an agency that has experienced the departure of over 3,000 staff members, including division heads, in the past year. The FDA is currently facing pressure to restore confidence among industry and public health groups due to concerns that the regulator has become overly politicized. Overton, a doctor by training, currently serves as the deputy director of the White House domestic policy council and previously worked at the America First Policy Institute, a conservative think tank. She received her medical degree from the University of New Mexico, trained in general surgery at Johns Hopkins, and pursued clinical-investigation research training at the Johns Hopkins Bloomberg School of Public...