FDA Announces Voluntary Recall of Some Eye-Care Products

By Jane Farrell

Several eye-care products by products by Altaire Pharmacuticals, sold at Walgreen’s, have been voluntarily recalled because of their potential for non-sterility, the federal Food and Drug Administration  (FDA) says.

Products sold by CVS were included in the recall.  To read about the CVS products, click here.

The recall, announced in July 2019, affects the following Walgreen’s products and indicates the periods of time during which they were sold:

Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL. Lot Number 19095, Expiration Date: 04/21, Manufacturer 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 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 Ship Date: 05/08/19.

Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL.  (Two Lot Numbers) (1) Lot Number 19105, Expiration Date: 04/22, Manufacturer Ship Date: 05/24/19 and (2) Lot Number 19050, Expiration Date: 02/22, Manufacturer Ship Date: 05/23/19.

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 Ship Date: 05/24/19.

The products are manufactured and labeled exclusively for Walgreens, the FDA said. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Information provided by the FDA; for more on health and consumer issues, click here to visit the agency’s website.