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Altaire Pharmaceuticals, Inc., is voluntarily recalling the Over-the-Counter (OTC) drug products sold at CVS Health. 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.

See recall notice to see specific Lot Numbers being recalled. The following products have lot numbers associated with the recall, the products are:

 

  •     CVS Health Natural Tears Lubricant Eye Drops Preservative Free (multiple lots)

  •     CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye (multiple lots)

  •     CVS Health Dry Eye Relief Eye Drops (multiple lots)

  •     CVS Health Preservative Free Lubricant Eye Drops Sensitive (multiple lots)

  •     CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief (two lots)

  •     CVS Health Lubricating Gel Drops for Anytime Use (three lots)

  •     CVS Health Overnight Lubricating Eye Ointment (multiple lots)

  •     CVS Health Lubricant Eye Ointment (multiple lots)

  •     CVS Health Extra Strength Lubricant Gel Drops single and twin Pack (multiple lots)

  •     CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy single and Twin Pack (multiple lots)

  •     CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution (multiple lots)

  •     CVS Health Preservative Free Lubricant Eye Drops Advanced Relief (multiple lots)

  •     CVS Health Lubricant Eye Drops Advanced Relief (multiple lots)

  •     CVS Health Fast Acting Lubricant Eye Drops Preservative Free (multiple lots)

  •     CVS Health Preservative Free Lubricant Eye Drops Fast Acting (multiple lots)

  •     CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief (three lots)

  •     CVS Health Multi-Action Relief Drops (multiple lots)

  •     CVS Health Lubricant Eye Drops Lasting Dry Eye Relief single and twin pack (multiple lots)

  •     CVS Health Maximum Redness Relief Eye Drops (multiple lots)

  •     CVS Health Redness Relief (multiple lots)

  •     CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief (multiple lots)

  •     CVS Health Lubricant Eye Ointment Sensitive Formula (two lots)

The products are manufactured and labeled exclusively for CVS Health. Altaire ships the products labeled for CVS only to CVS. The products are distributed at the retail level by CVS. 

Altaire has notified CVS announcing the recalls of the products/lots identified with specific directions for return of all units of the impacted lots.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.

  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.