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Walgreens Eye Drops and Ointment Recall

FDA Issues Notification of Recall Concerning Eye Drops and Ointments Sold Exclusively at Walgreens Pharmacy UNITED STATES – As reported online by www.winknews.com, the FDA has released a public health notification announcing a recall of certain eye products exclusively sold at Walgreens. Altaire Pharmaceuticals, the manufacturer of multiple eye products, issued a recall of certain […]

FDA Issues Notification of Recall Concerning Eye Drops and Ointments Sold Exclusively at Walgreens Pharmacy

FDA Issues Recall of Walgreens Eye Drops and Ointments

Walgreens Eye Drops and Ointments

UNITED STATES – As reported online by www.winknews.com, the FDA has released a public health notification announcing a recall of certain eye products exclusively sold at Walgreens.

Altaire Pharmaceuticals, the manufacturer of multiple eye products, issued a recall of certain eye drops and ointments that may have been non-sterile, posing a risk of harm to patients.  Walgreens Pharmacy is the exclusive retailer for some of Altaire’s eye products (including, among others, eye drops and ointments).

Altaire expressed concerns about the quality assurance process as it relates to certain products, finding that certain lots of its ophthalmic medications may not be sterile.  Non-sterile products can cause infections from exposure to bacteria and other microorganisms.  As such, Altaire is recalling all affected products.

Altaire has requested that Walgreens notify all customers of Altaire’s recall.  Affected products were labeled for Walgreens and sent directly for Walgreens, which distributed and sold the products directly to consumers.

Specific Information on Ophthalmic Products Subject to Recall

Altaire Pharmaceuticals have provided the following information regarding ophthalmic products subject to recall:

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 Risks of Using Non-Sterile Eye Products

When sterilized, products are free from harmful bacteria and other microorganisms.  Customers rely on sterile products and often assume that any medical product sold by a pharmacy is sterile and safe for use.  As such, when a product is found to be non-sterile, patients may be at risk of developing an infection.

If a patient has a compromised immune system (such as a child, elderly individual, or person with a chronic medical condition), the consequences of contracting an infection from a non-sterile product could be serious and potentially fatal.  So far, no illnesses or deaths have been reported regarding any of Altaire’s ophthalmic products, but a recall is essential to ensure patient safety moving forward.

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