CVS / Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products

Altaire Pharmaceuticals, Inc. Issues Voluntary Recall Of Multiple Ophthalmic Products Sold At CVS

Summary

Company Announcement Date:

July 10, 2019

FDA Publish Date:

July 10, 2019

Reason for Announcement:

Due to lack of assurance of sterility

Company Name:

Altaire Pharmaceuticals, Inc

Brand Name:

CVS Health

Product Description:

Multiple Ophthalmic Products

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Company Announcement

Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at CVS Health the during the time period as indicated in the tables below. As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

Detail about the original Altaire Recall at Recalls Global