How FDA drug recalls work
Sterility concerns at manufacturer Altaire Pharmaceuticals caused 189 lots of CVS’ store brand eye ointments to get recalled a week after a sweeping recall of prescription and over-the-counter eye ointments.
And so Altaire’s problem hits CVS as it did Altaire customers Walgreens and Walmart, whose store brands got yanked last week.
“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 company-written, FDA-posted recall notice states. “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.”
Look below for the CVS Health products recalled. Click here to find the lots recalled if you see your product:
Natural Tears Lubricant Eye Drops Preservative Free; Lubricant Eye Drops for Mild to Moderate Dry Eye; Dry Eye Relief Eye Drops, 15 ml and 30 ml; Preservative Free Lubricant Eye Drops Sensitive Solution, 30-count and 60-count packs; Lubricating Gel Drops for Anytime Use; Overnight Lubricating Eye Ointment; Lubricant Eye Ointment; Extra Strength Lubricant Gel Drops, single and Twin Pack; Fast Acting Lubricant Eye Drops Dry Eye Therapy, single and Twin Pack.
Preservative Free Lubricant Eye Drops Sensitive Solution, 30-count and 70-count packs; Preservative Free Lubricant Eye Drops Advanced Relief; Lubricant Eye Drops Advanced Relief; Fast Acting Lubricant Eye Drops Preservative Free, 24-count and 60-count; Lubricant Gel Drops-Moderate to Severe Dry Eye Relief; Multi-Action Relief Drops; Lubricant Eye Drops Lasting Dry Eye Relief, single or Twin Pack; Maximum Redness Relief Eye Drops; Redness Relief, 15 ml and 30 ml tubes; Lubricant Eye Drops Multi-Symptom Eye Relief; and Lubricant Eye Ointment Sensitive Formula.
Recalled products can be returned to the store for a refund.
Those with questions can call Altaire at 800-258-2471, 8:30 a.m. to 5 p.m., Eastern time, Monday through Friday, or email firstname.lastname@example.org.