Latest news with #BRSAnalyticalServices
Hindustan Times
14-05-2025
- Business
- Hindustan Times
Urgent FDA recall: Nearly 76k eye care products pulled over major safety concerns: Check list of affected items
The pharmaceutical consulting business BRS Analytical Services announced a countrywide recall of about 76,000 eye drop cases, as per FDA enforcement complaint. According to AvKare, a medical firm that first notified the recall, the urgent recall comes after an FDA audit discovered many cGMP discrepancies, which are alterations from the regular manufacturing method used during pharmaceutical production. The FDA also recalled the drops, which were intended to soothe dry, itchy eyes, because of a 'lack of assurance of sterility.' While the eye drops' present threat to health is unknown, potential hazards cannot be completely ruled out, according to AvKare. Customers have been advised to immediately stop use of the impacted products. NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution With expiration dates spanning from April 2025 to March 2027, the recalled items were distributed between May 2023 and April 2025. Also Read: Walmart hit by four food recalls in two months: Which products are affected? Consumers who want a complete refund, including shipping expenses, should return recalled items to AvKare. They will receive a return slip if they fill out a form that may be found on AvKare's website. They can fax it to 931-292-6229 or email it to customerservice@ After that, an organization will email the consumer a "Return to Authorization Form" so they can return the recalled item to the specified address and receive a complete refund, including shipping charges.
New York Post
14-05-2025
- Business
- New York Post
Over 75K eye care products recalled across US: See list of affected items
Nearly 76,000 cases of eye drops have been recalled nationwide by BRS Analytical Services, a pharmaceutical consulting firm, according to an FDA enforcement report. The urgent recall follows an FDA audit that found several cGMP deviations, which are departures from the standard manufacturing process during pharmaceutical production, according to AvKare, a medical manufacturer that originally reported the recall. The drops, used to relieve itchy, dry eyes, were also recalled due to a 'lack of assurance of sterility,' according to the FDA. Nearly 76,000 cases of AvKare eye drops have been recalled nationwide. The current health hazard posed to users of the eye drops is unknown, but possible risks cannot be ruled out, AvKare said. Customers should immediately stop use of the impacted products. Eye products that have been recalled so far: NDC #50268-043-15 Artificial Tears Ophthalmic Solution NDC #50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1% NDC #50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution NDC #50268-126-15 Lubricant Eye Drops Solution NDC #50268-678-15 Polyvinyl Alcohol Ophthalmic Solution The recalled products were shipped out May 2023 through April 2025, and have expiration dates ranging from April 2025 through March 2027. Customers can return the recalled products to AvKare for a full refund, including shipping costs. They should complete a form linked on AvKare's website and then fax or email it to the company to receive a return slip.
