FDA: Altaire Recalls Eye Drops, Ointments From Walgreens, Cites Sterility - NBC 5 Dallas-Fort Worth

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FDA: Altaire Recalls Eye Drops, Ointments From Walgreens, Cites Sterility

“Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility,” the FDA says

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    Altair Pharmaceuticals, Inc. is voluntarily recalling multiple eye drops and eye ointments exclusively made for and sold at Walgreens following concerns the products may not be sterile, the U.S. Food and Drug Administration announced.

    “Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility,” the FDA says.

    Using a non-sterile product that is meant to be sterile may result “in serious and potentially life-threatening infections or death,” according to the FDA.

    As of Thursday, Altaire has received no reports of adverse events. The FDA also says that Altaire has not received any adverse results out of sterility testing for the products.

    According to the FDA, the products are manufactured and labeled exclusively for Walgreens. Altaire notified Walgreens by e-mail on Wednesday announcing the recalls of the products/lots effected and has also requested the retailer notify it customers.

    The over-the-counter drug products and lots sold at Walgreens impacted by the recall are:

    • Lubricant Eye Drops Moisturizing Walgreens -- Item #: 801483; NDC #: 0363-0185-13; Package Size: 15 mL; Lot Number: 19095; Expiration Date: 04/21; Manufacturer Initial Ship Date: 05/14/19
    • Lubricant Eye Drops Moisturizing Twin Pack Walgreens -- Item #: 801477; NDC #: 0363-0185-49; Package Size: 2 x 15 mL; Lot Number: 19095; Expiration Date: 04/21; Manufacturer Initial Ship Date: 05/14/19
    • Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens -- Item #: 801482; NDC #: 0363-7500-50; Package Size: 3.5 gram; Lot Number: TCI; Expiration Date: 03/21; Manufacturer Initial Ship Date: 05/08/2019
    • Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens -- Item #: 801402; NDC #: 0363-0193-13; Package Size: 15 mL; Lot Number: 19105; Expiration Date: 04/22; Manufacturer Initial Ship Date: 05/24/2019
    • Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens -- Item #: 801402; NDC #: 0363-0193-13; Package Size: 15 mL; Lot Number: 19050; Expiration Date: 02/22; Manufacturer Initial Ship Date: 05/23/2019
    • Lubricant Eye Ointment PF Soothing Walgreens -- Item #: 801486; NDC #: 0363-0191-50; Package Size: 3.5 gram; Lot Number: TBD; Expiration Date: 04/22; Manufacturer Initial Ship Date: 05/24/2019

     

    Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc. at 1-800-258-2471 Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. They can also email otcdruggist@aol.com.

    The FDA says that customers should contact their physician or healthcare provider if they have experienced any problems or adverse effects that may be related to using this drug product.

    Eric Rojas/AFP/Getty Images