Latest news with #AvKARE
Yahoo
13-05-2025
- Health
- Yahoo
Thousands of eye care products sold nationwide are being recalled: See the list of impacted items
Be wary of what you put in your peepers: Nearly 76,000 cases of eye care products have been voluntarily recalled by their manufacturer following an audit by the U.S. Food and Drug Administration. BRS Analytical Service, LLC, is voluntarily recalling several of its eye drop products, according to a notice from pharmaceutical distributor AvKARE. While no specific health issues have been reported, the recall was prompted by 'manufacturing CGMP deviations' — meaning the products may not meet FDA quality standards. It's unclear whether these deviations pose a risk to users, so the company is recalling the products as a precaution. The affected products include artificial tears and other lubricating eye solutions and were first shipped between May 26, 2023, and April 21, 2025. They have expiration dates that range from April 2025 to March 2027 — meaning it's possible these items are still being used by customers. You can find specific information about what products are recalled on the FDA's website. Below are the products that are recalled: Artificial Tears Ophthalmic Solution Drug Code: 50268-043-15 13,872 cases recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Drug Code: 50268-066-15 1,610 cases recalled Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Drug Code: 50268-068-15 32,876 cases recalled Lubricant Eye Drops Solution (Polyethylene Glycol 400 / Propylene Glycol) Drug Code: 50268-126-15 13,104 cases recalled Polyvinyl Alcohol Ophthalmic Solution 1.4% Drug Code: 50268-678-15 14,333 cases recalled If you find that you have one of these products, stop using it immediately. Consumers who want a refund can fill out a recall form and send it to AvKARE by fax or email, after which they'll receive instructions to return the product and get a full refund, including shipping. This is not the first time in recent years that certain eye products have been the subject of scrutiny by the FDA. In October 2023, the FDA warned consumers about 26 over-the-counter eye care products, including eyedrops available at stores like CVS and Target, which came with the 'potential risk of eye infections that could result in partial vision loss or blindness.' At the time, the FDA discovered that the manufacturing facility had poor sanitation practices and that the products tested positive for bacteria, proving they weren't sterile as advertised. And in September 2023, the FDA issued warning letters to eight companies for illegally marketing unapproved eye products that claim to treat conditions like pink eye, cataracts and glaucoma, some of which had sterility issues and/or contained silver, which can cause long-term health issues. The news came one month after the FDA warned consumers not to use Dr. Berne's and LightEyez MSM eye drops due to contamination risks and the use of an unapproved ingredient. There was also an earlier wave of eye drop recalls in 2023, including one linked to EzriCare Artificial Tears that caused infections in dozens of people, resulting in hospitalizations, vision loss and at least one death, according to the FDA.
USA Today
13-05-2025
- Business
- USA Today
Eye care product recall: Search list of impacted items
Hear this story Ophthalmic products were voluntarily recalled due to a manufacturing deviation discovered during an audit by the U.S. Food and Drug Administration, a pharmaceutical company announced. The distributor of the products, AvKARE, said it was notified of the recall issued by BRS Analytical Service LLC, adding that manufacturing deviations "may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products." A notice posted by AvKARE urged consumers to stop using the affected products immediately. The products included in the recall were shipped between May 26, 2023, and April 21, 2025. Here is what you need to know. What products were recalled? Recalled items are listed in the database below, including their national drug code (NDC), lot number and expiration date. Need a break? Play the USA TODAY Daily Crossword Puzzle. What should consumers do? Buyers who may have these recalled products in their inventory are urged to complete a downloadable PDF "Quality to Return" form attached to the recall notice and fax it to 931-292-6229 or email it to customerservice@ Then, the company will send the customer a "Return to Authorization Form" to ship the recalled product back to the listed address to get a full credit, including shipping costs. Fernando Cervantes Jr. is a trending news reporter for USA TODAY. Reach him at and follow him on X @fern_cerv_.
Yahoo
13-05-2025
- Automotive
- Yahoo
Cooler recall expanded over amputation and crushing hazard
Igloo has expanded a recall of its coolers due to numerous reported injuries. In February, Igloo recalled 1,060,000 of its 90 Qt. Flip & Tow Rolling Coolers because the 'tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.' The recall came after 12 reports of fingertip injuries, including fingertip amputations, bone fractures, and lacerations due to the coolers. On May 9, the U.S. Consumer Product Safety Commission (CPSC) announced in a press release that Igloo was recalling 130,000 more of these rolling coolers. Since the initial recall was announced in February, Igloo has received 78 reports of fingertip injuries, 26 of which resulted in fingertip amputations, bone fractures, and lacerations. The additional recalled coolers were sold at Costco, Target, Academy, Dick's, and other stores nationwide and online at and other websites. They were sold from January 2019 through January 2025, and cost anywhere between $80 and $140. The affected products were manufactured before January 2024, with the manufacturing date on the bottom of the cooler in a circular pattern. There's also an arrow on the bottom of the cooler that points at the month of manufacture and the last two digits of the year of manufacture inside the circle. Coolers have a tow handle and the company's logo, 'IGLOO,' printed on the side. Products were also sold in many body and lid color combinations. The additional recalled coolers can be identified by one of these three SKU numbers: 34692, 34785, 34790. You can find the initial list of recalled coolers, with the SKU number, description, and date codes here. In addition, 20,000 coolers in Canada and 5,900 in Mexico are being recalled. Consumers should stop using the recalled coolers immediately. They can also contact Igloo for a free replacement handle. Many other popular products in the U.S. have been recalled in the last few months. This week, BRS Analytical Service, LLC announced an urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release. The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP). CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE. According to the FDA, the recall was issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon. The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
Yahoo
13-05-2025
- Automotive
- Yahoo
Cooler recall expanded over amputation and crushing hazard
Igloo has expanded a recall of its coolers due to numerous reported injuries. In February, Igloo recalled 1,060,000 of its 90 Qt. Flip & Tow Rolling Coolers because the 'tow handle can pinch consumers' fingertips against the cooler, posing fingertip amputation and crushing hazards.' The recall came after 12 reports of fingertip injuries, including fingertip amputations, bone fractures, and lacerations due to the coolers. On May 9, the U.S. Consumer Product Safety Commission (CPSC) announced in a press release that Igloo was recalling 130,000 more of these rolling coolers. Since the initial recall was announced in February, Igloo has received 78 reports of fingertip injuries, 26 of which resulted in fingertip amputations, bone fractures, and lacerations. The additional recalled coolers were sold at Costco, Target, Academy, Dick's, and other stores nationwide and online at and other websites. They were sold from January 2019 through January 2025, and cost anywhere between $80 and $140. The affected products were manufactured before January 2024, with the manufacturing date on the bottom of the cooler in a circular pattern. There's also an arrow on the bottom of the cooler that points at the month of manufacture and the last two digits of the year of manufacture inside the circle. Coolers have a tow handle and the company's logo, 'IGLOO,' printed on the side. Products were also sold in many body and lid color combinations. The additional recalled coolers can be identified by one of these three SKU numbers: 34692, 34785, 34790. You can find the initial list of recalled coolers, with the SKU number, description, and date codes here. In addition, 20,000 coolers in Canada and 5,900 in Mexico are being recalled. Consumers should stop using the recalled coolers immediately. They can also contact Igloo for a free replacement handle. Many other popular products in the U.S. have been recalled in the last few months. This week, BRS Analytical Service, LLC announced an urgent recall of five eye care products, healthcare distributor AvKARE shared in a recent press release. The recall comes after a Food and Drug Administration (FDA) audit identified violations of Current Good Manufacturing Practice (CGMP). CGMP regulations for drugs contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product. Although it's unclear what health risks may be posed, CGMP deviations could lead to 'unacceptable quality' of the recalled eyecare solutions, and it's 'not possible to rule out patient risks resulting from use of these products,' according to AvKARE. According to the FDA, the recall was issued due to a 'lack of assurance of sterility' in these products. The recall affects more than 1.8 million cartons of eye drops. Earlier this month, popular wellness brand Optimal Carnivore issued a voluntary recall on 1,500 bottles of their Bone & Joint Restore capsules, after they were distributed nationwide through major retailers, such as Amazon. The capsules, which contain bone marrow and bones from cows, were recalled due to potential salmonella contamination. Salmonella infection is a common bacterial disease that can affect the intestinal tracts and occurs after drinking contaminated water, eating raw meat, poultry, eggs, or unpasteurized milk.
Yahoo
13-05-2025
- Business
- Yahoo
Eye Care Product Recall From Trusted Distributor Includes 1000s of Cases
A sweeping voluntary recall has been issued for over-the-counter eye care products—including artificial tears and other ophthalmic solutions—after a U.S. Food and Drug Administration (FDA) audit uncovered a manufacturing deviation that may pose a health risk to consumers. Pharmaceutical distributor AvKARE was alerted by BRS Analytical Services LLC, the recalling firm, that several batches of eye care products may be of "unacceptable quality." While specific health hazards remain unknown, officials say the potential risk to patients cannot be ruled out. The FDA is reportedly aware of the recall. Consumers are urged to stop using the recalled products immediately and follow the return procedures outlined in AvKARE's recall notice. Affected items were distributed between May 26, 2023, and April 21, 2025, and include: 13,104 cases of Lubricant Eye Drops Solution 32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution 14,333 cases of Polyvinyl Alcohol Ophthalmic Solution 1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1% 13,872 cases of Artificial Tears Ophthalmic Solution Each of these products is identified by its national drug code (NDC), available on the FDA's recall website and AvKARE's press release. Consumers, retailers, and healthcare providers who may have inventory of the affected products should complete the "Quality to Return" form provided in the recall notice and send it to AvKARE via fax or email. Upon confirmation, customers will receive return instructions and a full refund, including recall follows other recent product withdrawals related to quality control issues, underscoring the importance of FDA oversight in consumer health products, especially everyday essentials like eyecare products.
