Perrigo Eye Ointment Recall [US]


US FlagUS/Silver Spring: Logo - PerrigoAltaire Pharmaceuticals Inc, an Aquebogue, New York establishment, recalls certain batch/lots of multiple Ophthalmic (Eye) Drop, Gel and Ointment products sold by Perrigo 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/Qvcs30p5VkJ

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

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

  • Perrigo Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4250-35. 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.
  • Perrigo NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4160-35. 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.
  • Perrigo NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4144-35. 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.
  • Perrigo OLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4021-35. 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.
  • Perrigo Bacitracin Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4022-35. 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.
  • Perrigo Sulfacetamide Sodium Ophthalmic Ointment, sold in 3.5 gm packages with a NDC number of 0574-4190-35. 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.
  • Perrigo Puralube Ophthalmic Ointment (please note: Puralube is an OTC product), sold in 3.5 gm packages with a NDC number of 0574-4190-35. 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.

According to the FDA, Altaire Pharmaceuticals has recalled various over-the-counter (“OTC”) Eye Medications sold by Perrigo 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 Ointment products identified above.

If you believe you have purchased or have in your possession any of the recalled Eye 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 Perrigo Company PLC. Altaire ships the products only to Perrigo Company PLC. The products are distributed by Perrigo Company PLC.

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

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More information about this recall:
Recalls Direct RIN: 11745-2019
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