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Altaire Pharmaceuticals, Inc. Issues Voluntary Recall of Multiple Ophthalmic Products Sold at Walgreens

July 3, 2019

Audience: Consumer, Health Professional, Pharmacy

July 3, 2019 -- Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Over-the-Counter (OTC) drug products and lots, within expiry, sold at Walgreens during the time period as indicated in the tables below. 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 above. No other lots are being recalled.

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 specifications results including Sterility testing, for the products.

Product Description: Lubricant Eye Drops Moisturizing
Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19095 04/21 05/14/19

Product Description: Lubricant Eye Drops Moisturizing Twin Pack
Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19095 04/21 05/14/19

Product Description: Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment
Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
TCI 03/21 05/08/2019

Product Description: Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops
Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL

Lot Number Expiration Date Manufacturer Initial Ship Date
19105 04/22 05/24/2019
19050 02/22 05/23/2019

Product Description: Lubricant Eye Ointment PF Soothing
Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram

Lot Number Expiration Date Manufacturer Initial Ship Date
TDB 04/22 05/24/2019

The products are manufactured and labeled exclusively for Walgreens. Altaire ships the products labeled for Walgreens only to Walgreens. The products are distributed at the retail level by Walgreens. Altaire has also requested that Walgreens notify its customers.
Altaire has notified Walgreens by e-mail on July 3, 2019 announcing the recalls of the products/lots identified herein, with specific directions for return of all units of the impacted lots.

Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday through Friday from 8:30 a.m. to 5:00 p.m. ET. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Altaire 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.

Source: FDA

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