Altaire Pharmaceuticals, which sells its products exclusively at Walgreens, has issued a voluntary recall of eye drops and other ophthalmic products, the Food and Drug Administration announced.
The recall was issued over management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility which could have led to some of the products being non-sterile. The FDA says using a "non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death."
No adverse effects from the products have been reported.
Only the following products have been affected:
Product Description: Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL
Product Description: Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL
Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram
Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL
Product Description: Lubricant Eye Ointment PF Soothing Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram
Customers can contact Altaire directly with questions regarding the recall by calling 1-800-258-2471, or emailing firstname.lastname@example.org Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. Click or tap here for more information.
Altaire told the FDA it "takes its mission of customer safety and providing quality products very seriously. The company is committed to, and diligently working to, ensure the sufficiency of Quality Assurance controls over critical systems in its manufacturing facility."
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