Accutome, Focus Ointment, Grandall & Prestige Eye Drops


US FlagUS/Silver Spring: Logo - Altaire PharmaAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold by various third-party companies including Accutome, Focus Laboratories, Grandall Distributing and Prestige 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/82sg30p9QdA

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

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

  • Accutome:
    • Accutome Accu-Wash, sold in 4 fluid bottles with an NDC number of 63448-411-04. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
  • Focus Laboratories:
    • FreshKote Lubricant Eye Drops, sold in 15 mL bottles with an NDC number of 15821-101-15. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
  • Grandall Distributing Co., Inc:
    • Grandall Colirio Ojo De Aguila Eye Drops, sold in 15 mL bottles with no NDC number supplied. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Grandall Colirio Oftal-Mycin Redness Relief Eye Drops, sold in 15 mL bottles with no NDC number supplied. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Grandall Oftal-Mycin Ophthalmic Ointment, sold in 3.5 gram containers with no NDC number supplied. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
  • Prestige:
    • Clear Eyes Redness Relief, sold in 15 mL bottles with a UPC of 6-78112-25415-6. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Clear Eyes Redness Relief, sold in 30 mL bottles with a UPC of 6-78112-25419-4. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Clear Eyes Redness Relief (Handy Pocket Pal), sold in 0.2 fluid ounce bottles with a UPC of 6-78112-15418-7. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Clear Eyes Redness Relief (Little Drug), sold in 0.2 fluid ounce bottles with a UPC of 7-92554-70103-7. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.
    • Clear Eyes Redness Relief (Select Corp), sold in 0.2 fluid ounce bottles with a UPC of 6-55708-01039-6. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site.

According to the FDA, Altaire Pharmaceuticals has recalled various over-the-counter (“OTC”) and prescription Eye Medications sold by Accutome, Focus Laboratories, Grandall Distributing and Prestige 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 above products are labeled exclusively for Accutome, Focus Laboratories, Grandall Distributing and Prestige. Altaire ships the products labeled for Accutome, Focus Laboratories, Grandall Distributing and Prestige only to Accutome, Focus Laboratories, Grandall Distributing Co. Inc. and Prestige, respectively.

==> 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 by Accutome, please search for “Accutome” using the Search Box at the top of this page.

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

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

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

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More information about this recall:
Recalls Direct RIN: 11791-2019

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