According to the notice, over-the-counter ophthalmic products were voluntarily recalled due to manufacturing deviations discovered during an audit by the US Food and Drug Administration.
Pharmaceutical distributor Avkare has been notified of consumer-level drug recalls by recall company BRS Analytical Services LLC. The recalls were issued for several products as a result of a manufacturing deviation that “it could lead to products of unacceptable quality and the risks to patients due to the use of these products cannot be ruled out.”
This notification warns consumers to immediately stop using the affected products. Avkare said the FDA is aware of the recall and that the health hazard linked to the item is unknown.
USA Today contacted Avkare for more details.
When was the item distributed?
The recalled products were shipped from May 26, 2023 to April 21, 2025, Avkare said.
Which products were spontaneously recalled?
Avkare’s press release includes a detailed chart containing the lot numbers and expiration dates for the recall products listed below: Recall notifications posted on the FDA website identified the amount of cases associated with the recall.
- 13,104 cases of lubricant eye drop solutions; National Drug Code (NDC): 50268-126-15
- 32,876 cases of sodium carboxymethylcellulose ocular solution; National Drug Code (NDC): 50268-068-15
- 14,333 cases of polyvinyl alcohol eye solutions; National Drug Code (NDC): 50268-678-15
- Carboxymethylcellulose ophthalmic gel sodium 1% 1,610 cases 1%; National Drug Code (NDC): 50268-066-15
- Cases of 13,872 artificial tear liquid solution; National Drug Code (NDC): 50268-043-15
What should consumers do?
Buyers who may have these recall products in stock will be urged to fill out the “Quality” of the downloadable PDF in the form attached to the recall notification and faxed at 931-292-6229, or email customerservice@avkare.com.
The company then sends the customer “Return to Authorization Form” to return the recalled product to the listed address and obtain a full credit including shipping costs.
Taylor Ardley is a news reporter for USA Today. You can contact her at Tardrey@gannett.com.