LOS ANGELES - Altaire Pharmaceuticals, Inc., has issued a voluntary recall for 30 different types of CVS Health brand over-the-counter eye drops due to concerns about sterility of the products.
No cases of adverse side effects as a result of product use have been reported to Altaire, the company said.
The recall is a precautionary move in response to management concerns that the quality assurance controls over critical systems in the manufacturing facility were not sufficient during production of the products.
When the FDA looked into the matter, it determined that the issues presented by management did indicate a lack of sterility assurance.
Eye drops are supposed to be a sterile product, and use of compromised non-sterile products can lead to serious and potentially life threatening infections or death.
Altaire notified CVS by email on Wednesday announcing the voluntary recall, which is being conducted with the knowledge of the FDA.
The FDA has provided a complete list of the products being recalled, including the item number, lot number and expiration date of each recalled product. This information can also be located on the label of any bottle of eye drops that has already been purchased.
The FDA encourages any consumer who has experienced problems that may be related to these products to contact a doctor. Any adverse reactions can also be reported to the FDA's MedWatch Adverse Event Reporting program.