Additional eye drops and eye ointment have been recalled because of quality concerns that could lead to infection or even death.
Altair Pharmaceuticals said that the products, sold at CBS stores, were being recalled as a precautionary measure “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”
The recall information was published on the Food and Drug Administration (FDA) website.
“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,” the company added.
No reports of adverse reactions to the products have been received, the company added.
The latest recall came after Altaire announced it was recalling drug products and lots sold at Walgreens.
“As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. This recall is being carried out to the retail level and is only for the specific lots listed,” it stated.
“Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specification results including sterility testing, for the products.”
A third recall was for products sold at Walmart, the company said in a notice published July 5.
Altaire also recently recalled other prescription drug products and lots over potential nonsterility, naming among them “Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment NDC” and “NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment.”
Altaire can be reached by calling 1-800-258-2471, or e-mailing [email protected] Monday through Friday from 8:30 a.m. to 5:00 p.m. ET.
A list of all of the recalled products and item numbers being sold at CVS follows:
- CVS Health Natural Tears Lubricant Eye Drops Preservative Free; Item number: 538397
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye; Item number: 317916
- CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye; Item number: 247887
- CVS Health Dry Eye Relief Eye Drops; Item number: 317914
- CVS Health Dry Eye Relief Eye Drops; Item number: 457802
- CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 495334
- CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 994883
- CVS Health Preservative-Free Lubricant Gel Drops Dry Eye Relief; Item number: 634634
- CVS Health Lubricating Gel Drops for Anytime Use; Item number: 563420
- CVS Health Overnight Lubricating Eye Ointment; Item number: 881532
- CVS Health Lubricant Eye Ointment; Item number: 247881
- CVS Health Extra Strength Lubricant Gel Drops; Item number: 799143
- CVS Health Extra Strength Lubricant Gel Drops Twin Pack; Item number: 258587
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy; Item number: 895160
- CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack; Item number: 994881
- CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 495301
- CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 457791
- CVS Health Preservative-Free Lubricant Eye Drops Advanced Relief; Item number: 563442
- CVS Health Lubricant Eye Drops Advanced Relief; Item number: 563419
- CVS Health Fast Acting Lubricant Eye Drops Preservative Free; Item number: 994882
- CVS Health Preservative-Free Lubricant Eye Drops Fast Acting; Item number: 258625
- CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief; Item number: 799145
- CVS Health Multi-Action Relief Drops; Item number: 694954
- CVS Health Lubricant Eye Drops Lasting Dry Eye Relief; Item number: 968210
- CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack; Item number: 495323
- CVS Health Maximum Redness Relief Eye Drops; Item number: 994880
- CVS Health Redness Relief; Item number: 317912
- CVS Health Redness Relief; Item number: 457799
- CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief; Item number: 563431
- CVS Health Lubricant Eye Ointment Sensitive Formula; Item number: 247885
