Altaire Pharmaceuticals is recalling various over-the-counter (OTC) eye care products sold at Walgreens.
Concerns have been raised regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.
Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
The firm has received no reports of adverse events.
The following products are being recalled:
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
The recalled products were manufactured, labeled exclusively, and and sold at the retail level only by Walgreens. Altaire has also requested that Walgreens notify its customers.
What to do
Consumers with may contact Altaire at (800) 258-2471 Monday through Friday from 8:30 a.m. to 5:00 p.m. (ET) or by e-mail at firstname.lastname@example.org.