CVS Health Eye Drop, Ointment & Solution Recall [US]


US FlagUS/Silver Spring: Logo - CVS HealthAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold at CVS Health under the CVS 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/iPOV30p85x7

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

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

  • CVS Health Natural Tears Lubricant Eye Drops Preservative Free, sold in 0.6 mL bottles by 32 count cases with a CVS item of 538397 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, sold in 15 mL bottles with a CVS item of 317916 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye, sold in 30 mL bottles with a CVS item of 247887 and no listed NDC number. 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.
  • CVS Health Dry Eye Relief Eye Drops, sold in 15 mL bottles with a CVS item of 317914 and no listed NDC number. 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.
  • CVS Health Dry Eye Relief Eye Drops, sold in 30 mL bottles with a CVS item of 457802 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, sold in 0.6 mL bottles by 60 count with a CVS item of 495334 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, sold in 0.6 mL bottles by 30 count with a CVS item of 994883 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief, sold in 0.6 mL bottles by 30 count with a CVS item of 634634 and no listed NDC number. 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.
  • CVS Health Lubricating Gel Drops for Anytime Use, sold in 10 mL bottles with a CVS item of 563420 and no listed NDC number. 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.
  • CVS Health Overnight Lubricating Eye Ointment, sold in 3.5 gram containers with a CVS item of 881532 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Ointment, sold in 3.5 gram containers with a CVS item of 247881 and no listed NDC number. 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.
  • CVS Health Extra Strength Lubricant Gel Drops, sold in 15 mL bottles with a CVS item of 799143 and no listed NDC number. 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.
  • CVS Health Extra Strength Lubricant Gel Drops Twin Pack, sold 2 by 15 mL bottles with a CVS item of 258587 and no listed NDC number. 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.
  • CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy, sold in 15 mL bottles with a CVS item of 895160 and no listed NDC number. 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.
  • CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack, sold in 2 by 10 mL bottles with a CVS item of 994881 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, sold in 0.6 mL bottles by 30 count with a CVS item of 495301 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution, sold in 0.6 mL bottles by 70 count with a CVS item of 457791 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Advanced Relief, sold in 0.6 mL bottles by 30 count with a CVS item of 563442 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops Advanced Relief, sold in 10 mL bottles with a CVS item of 563419 and no listed NDC number. 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.
  • CVS Health Fast Acting Lubricant Eye Drops Preservative Free, sold in 0.6 mL bottles by 24 count with a CVS item of 994882 and no listed NDC number. 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.
  • CVS Health Preservative Free Lubricant Eye Drops Fast Acting, sold in 0.6 mL bottles by 60 count with a CVS item of 258625 and no listed NDC number. 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.
  • CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief, sold in 30 mL bottles with a CVS item of 799145 and no listed NDC number. 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.
  • CVS Health Multi-Action Relief Drop, sold in 15 mL bottles with a CVS item of 694954 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, sold in 10 mL bottles with a CVS item of 968210 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack, sold 2 by 10 mL bottles with a CVS item of 495323 and no listed NDC number. 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.
  • CVS Health Maximum Redness Relief Eye Drops, sold in 15 mL bottles with a CVS item of 994880 and no listed NDC number. 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.
  • CVS Health Redness Relief, sold in 15 mL bottles with a CVS item of 317912 and no listed NDC number. 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.
  • CVS Health Redness Relief, sold in 30 mL bottles with a CVS item of 457799 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief, sold in 15 mL bottles with a CVS item of 563431 and no listed NDC number. 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.
  • CVS Health Lubricant Eye Ointment Sensitive Formula, sold in 3.5 gram containers with a CVS item of 247885 and no listed NDC number. 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 CVS 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 CVS Health under the CVS product brand. Altaire ships the products labeled for CVS only to CVS.

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

___________________________________________________________

More information about this recall:
Recalls Direct RIN: 11772-2019

Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food or drug you purchased in the US [external: new window opens]:
==> http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm095859.htm
Search for a recalled food or drug on the US FDA Web archive [external: new window opens]:
==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

We welcome your feedback:
Want to e-mail or share this recall?
==> Simply use the “Share this” options below.
Is this recall relevant to you? Please let us know!
==> Click on the “Like” button below.
E. & O. E.

___________________________________________________________

Advertisements
%d bloggers like this: