OCuSOFT Eye Drop, Ointment & Solution Recall [US]


US FlagUS/Silver Spring: Logo - OCuSOFTAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold under the OCuSOFT 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/ivLp30p9jI8

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

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

  • OCuSOFT branded Homatropine Hydrobromide Ophthalmic Solution 5%, sold in 0.5 mL bottles with an NDC number of 54799-431-05. 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.
  • OCuSOFT branded Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5%, sold in 15 mL bottles with an NDC number of 54799-502-15. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • OCuSOFT branded Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, sold in 15 mL bottles with an NDC number of 54799-503-15. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • OCuSOFT branded Tetravisc Forte, sold in 0.6 mL bottles with 12 bottles/case with an NDC number of 54799-504-01. 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.
  • OCuSOFT branded Tetravisc Forte, sold in 5 mL bottles with an NDC number of 54799-504-05. 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.
  • OCuSOFT branded Tetravisc, sold in 0.6 mL bottles with 12 bottles/case with an NDC number of 54799-505-01. 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.
  • OCuSOFT branded Tetravisc, sold in 5 mL bottles with an NDC number of 54799-505-05. 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.
  • OCuSOFT branded Flucaine, sold in 5 mL bottles with an NDC number of 54799-507-21. 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.
  • OCuSOFT branded Eye Wash, sold in one (1) fluid ounce bottles with an NDC number of 54799-565-01. 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.
  • OCuSOFT branded Eye Wash, sold in four (4) fluid ounce bottles with an NDC number of 54799-565-59. 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.
  • OCuSOFT branded Tears Again Lubricant Eye Drops, sold in 15 mL bottles with an NDC number of 54799-904-15. Additional information such recalled batch/lot numbers, expiration dates and manufacturer initial ship dates for this products can be found on the Web site above.
  • OCuSOFT branded Tears Again Lubricant Eye Drops, sold in 30 mL bottles with an NDC number of 54799-904-30. 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.
  • OCuSOFT branded Tears Again Lubricant Eye Ointment Nighttime Relief, sold in 3.5 gram containers with an NDC number of 54799-906-35. 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.
  • OCuSOFT branded Retaine NaCl Ophthalmic Ointment, sold in 3.5 gram containers with a SKU number of 777-3-76. 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.
  • OCuSOFT branded Retaine NaCl Ophthalmic Solution, sold in 15 mL bottles with a SKU number of 777-3-77. 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”) and prescription OCuSOFT branded Eye Medications 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 OCuSOFT under the OCuSOFT product brand. Altaire ships the products labeled for OCuSOFT only to OCuSOFT.

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

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More information about this recall:
Recalls Direct RIN: 11784-2019

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