Walgreens Eye Drop, Ointment & Solution Recall [US]


US FlagUS/Silver Spring: Logo - WalgreensAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold at Walgreens under the Walgreens 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/nDmu30p5yHr

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

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

  • Walgreens Lubricant Eye Drops Moisturizing Twin Pack, sold in 2 by 15 mL packages with a Walgreens item of 801477 and a NDC number of 0363-0185-49. 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.
  • Walgreens Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, sold in 3.5 gram packages with a Walgreens item of 801482 and a NDC number of 0363-7500-50. 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.
  • Walgreens Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, sold in 15 mL packages with a Walgreens item of 801402 and a NDC number of 0363-0193-13. 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.
  • Walgreens Lubricant Eye Ointment PF Soothing, sold in 3.5 gram packages with a Walgreens item of 801486 and a NDC number of 0363-0191-50. 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 Walgreens 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 Walgreens under the Walgreens product brand. Altaire ships the products labeled for Walgreens only to Walgreens.

==> 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 Walgreens brand name, please search for “Walgreens” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11738-2019

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General information:
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