HOUSTON – Altaire Pharmaceuticals Inc. has voluntarily recalled several of its eye products that are exclusively sold at Walgreens due to concerns that they are not sterile, according to the U.S. Food and Drug Administration.
Multiple eyes drops and ointments from the company may not be sterile, amd using a non-sterile product could result in serious and potentially life-threatening infections or death, according to the FDA.
“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 said.
Company officials said there have been no reports of adverse events.
Here is a list of the products affected:
- Lubricant Eye Drops Moisturizing Walgreens -- Item No. 801483; NDC No. 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 No.: 801477; NDC No.: 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 No.: 801482; NDC No.: 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 No. 801402; NDC No. 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 No.: 801402; NDC No.: 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 No.: 801486; NDC No.: 0363-0191-50; Package Size: 3.5 gram; Lot Number: TBD; Expiration Date: 04/22; Manufacturer Initial Ship Date: 05/24/2019
Customers with any concerns or questions are asked call Altaire Pharmaceuticals Inc. at 1-800-258-2471.