Recall On Eye Drops Sold At Walmart And Walgreens May Not Be Sterile

July 11, 2019

 

 

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

Company Announcement Date: July 03, 2019

FDA Publish Date: July 03, 2019

Product Type: Drugs

Reason for Announcement: Potential for nonsterility

Company Name: Altaire Pharmaceuticals, Inc.

Brand Name: Walgreens

Product Description: Eye drops and ophthalmic ointments

Company Announcement

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 NumberExpiration DateManufacturer Initial Ship Date

1909504/2105/14/19

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

 

Lot NumberExpiration DateManufacturer Initial Ship Date

1909504/2105/14/19

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

 

Lot NumberExpiration DateManufacturer Initial Ship Date

TCI03/2105/08/2019

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

 

Lot NumberExpiration DateManufacturer Initial Ship Date

1910504/2205/24/2019

1905002/2205/23/2019

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

 

Lot NumberExpiration DateManufacturer Initial Ship Date

TDB04/2205/24/2019

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.

  • Complete and submit the report Online

  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

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.

 

 

 

 

 

 

Walmart recalled products

  • Equate Restore Tears Lubricant Eye Drops Twin Pack: 49035-189-49.

  • Equate Eye Allergy Relief Drops: 49035-887-13.

  • Equate Sterile Lubricant Stye Ointment: 49035-875-50.

  • Equate Comfort Gel Lubricant Eye Gel Twin Pack: 49035-197-49.

  • Equate Restore PM Nighttime Lubricant Eye Ointment: 49035-191-50.

  • Equate Night & Day Restore Tears Lubricant Eye Pack: 49035-883-59.

  • Equate Support Advanced Twin Pack: 49035-885-49.

  • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free: 49035-882-54.

  • Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free: 49035-882-52.

  • Equate Support Moisture Lubricant Eye Drops: 49035-145-10.

  • Support Harmony Lubricant Eye Drops: 49035-145-10.

 

 

 

 

Please reload

Featured Posts

Billings Police Ratings

December 27, 2019

1/6
Please reload

Recent Posts
Please reload

Search By Tags

I'm busy working on my blog posts. Watch this space!

Please reload

Follow Us
  • Facebook Classic
  • Twitter Classic