Walmart Equate Eye Drop, Gel & Ointment Recall [US]


US FlagUS/Silver Spring: Logo - WalmaryAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold at Walmart under the Equate brand due to possible non-sterility and/or consequential risks of bacterial, viral or mold infection, severe illness and/or possible life-changing complications, all serious health hazards.

FDA: http://ht.ly/c3Lh30p55RE

Direct link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/altaire-pharmaceuticals-inc-issues-voluntary-recall-multiple-ophthalmic-products-sold-wal-mart

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Eye Drop, Gel and Ointment products are subject to this recall:

  • Equate Restore Tears Lubricant Eye Drops Twin Pack, sold in 2 by 15 mL packages with a Walmart item number of 552374320 and a NDC number of 49035-189-49. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Eye Allergy Relief Drops, sold in 15 mL packages with a Walmart item number of 567371432 and a NDC number of 49035-887-13. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Sterile Lubricant Stye Ointment, sold in 15 mL packages with a Walmart item number of 563031651 and a NDC number of 49035-875-50. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Comfort Gel Lubricant Eye Gel Twin Pack, sold in 2 by 15 mL packages with a Walmart item number of 552374319 and a NDC number of 49035-197-49. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Restore PM Nighttime Lubricant Eye Ointment, sold in 3.5 gram packages with a Walmart item number of 551282425 and a NDC number of 49035-191-50. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Night & Day Restore Tears Lubricant Eye Pack, sold in 3.5 gram and 15 mL packages with a Walmart item number of 551282425 and a NDC number of 49035-883-59. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Support Advanced Twin Pack, sold in 2 by 15 mL packages with a Walmart item number of 567371433 and a NDC number of 49035-885-49. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, sold in 25 count (0.6 mL fill) packages with a Walmart item number of 563031654 and a NDC number of 49035-882-54. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Equate Support Moisture Lubricant Eye Drops, sold in 10 mL packages with a Walmart item number of 553503238 and a NDC number of 49035-145-10. Additional information such specific batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • Support Harmony Lubricant Eye Drops, sold in 10 mL packages with a Walmart item number of 553503238 and a NDC number of 49035-145-10. Please note: Support Harmony packaging was discontinued in January 2018. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.

According to the FDA, Altaire Pharmaceuticals has recalled various over-the-counter (“OTC”) Eye Medications sold at Walmart during the time period as indicated on the FDA Web site listed above. Altaire initiated this recall due to management concerns regarding the sufficiency of quality assurance controls over critical systems in the manufacturing facility that are in place to provide product sterility. You should not use the recalled Eye Drop, Gel and Ointment products identified above.

If you believe you have purchased or have in your possession any of the recalled Eye Drop, Gel and Ointment products, please do not consume them directly nor use them as an ingredient in another preparation. Instead, return the medications to the store where you purchased it for a full refund.

In general, the administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death. To date, however, Altaire has not received any reports of adverse events, nor has Altaire obtained any out of specifications results including sterility testing, for the products.

The products are manufactured and labeled exclusively for Walmart under the Equate product brand. Altaire ships the products labeled for Walmart only to Walmart.

==> If you have a medical emergency, please contact 9-1-1, your closest hospital or emergency center equipped to handle bacterial, viral or mold infection.

If you have any questions about this recall, please contact Altaire Pharmaceuticals Inc. toll-free at 1-800-258-2471 from 8:30 AM to 5:00 PM Eastern Standard Time, Monday to Friday or by e-mail at otcdruggist@aol.com.

==> To see other recalls and notifications caused by suspected faulty and/or dangerous Eye Drop, Gel and Ointment products, please search for “eye” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by suspected Clostridium botulinum contamination, please search for “Botulinum” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by possible E. coli contamination, please search for “E. coli” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by possible Listeria monocytogenes contamination, please search for “Listeria” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by possible Mold contamination, please search for “mold” using the Search Box at the top of this page.

==> To see other recalls and notifications caused by possible Salmonella contamination, please search for “Salmonella” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Altaire Pharmaceuticals Inc., please search for “Altaire” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the Equate brand name, please search for “Walmart” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11731-2019
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