Eye Drops Sold at Walmart, Walgreens Recalled: FDA

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Chicago Sun-Times

July 8, 2019

Some over-the-counter eye drops and ointments have been recalled over concerns the products may not be sterile. Time to check the medicine cabinet.

Select over-the-counter eye drops and ointments sold at Walgreens and Walmart stores as well as some prescription ointments sold at other retailers have been recalled over concerns the products may not be sterile.

New York-based Altaire Pharmaceuticals Inc. issued voluntary recalls for Walgreens and Walmart store brand products and a third recall for Perrigo prescription ointments, according to recall notices posted on the Food and Drug Administration’s website.

According to the recall notices, there are 23 affected products under different product name and brands and 150 affected lots that have the “potential for nonsterility.”

The recalls are being called a “precautionary measure,” and “Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including sterility testing, for the products.”

“Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death,” the recall notices state.

Walgreens recalled products

Altaire has recalled five different products from Walgreens that were produced for the drugstore chain, with six lots affected, according to the recall notice. Here are the products with their National Drug Code (NDC) listed and lot numbers:

  • Lubricant Eye Drops Moisturizing: 0363-0185-13; lot 19095.
  • Lubricant Eye Drops Moisturizing Twin Pack: 0363-0185-49; lot 19095.
  • Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment: 0363-7500-50; lot TCI.
  • Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops: 0363-0193-13; lots 19105 and 19050.
  • Lubricant Eye Ointment PF Soothing: 0363-0191-50; lot TDB.

Walmart recalled products

Altaire is recalling 74 lots from Walmart, which include 10 Equate products and one eye drop under the Support Harmony brand, which was discontinued in January 2018, according to the recall notice.

Here are the product names and NDC numbers. For list of affected lots, see the recall notice.

  • Equate Restore Tears Lubricant Eye Drops Twin Pack: 49035-189-49.
  • Equate Eye Allergy Relief Drops: 49035-887-13.
  • Equate Sterile Lubricant Stye Ointment: 49035-875-50.
  • Equate Comfort Gel Lubricant Eye Gel Twin Pack: 49035-197-49.
  • Equate Restore PM Nighttime Lubricant Eye Ointment: 49035-191-50.
  • Equate Night & Day Restore Tears Lubricant Eye Pack: 49035-883-59.
  • Equate Support Advanced Twin Pack: 49035-885-49.
  • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free: 49035-882-54.
  • Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free: 49035-882-52.
  • Equate Support Moisture Lubricant Eye Drops: 49035-145-10.
  • Support Harmony Lubricant Eye Drops: 49035-145-10.

Perrigo recalled products

Altaire recalled 59 lots of six prescription ointments and 11 lots of the over-the-counter Puralube Ophthalmic Ointment, which were “manufactured and labeled exclusively for Perrigo Company PLC.” The products were distributed by Perrigo, the recall notice stated.

Here are the product names and NDC numbers. For list of affected lots, see the recall notice.

  • Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment: 0574-4250-35.
  • NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment: 0574-4160-35.
  • NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment: 0574-4144-35.
  • POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment: 0574-4021-35.
  • Bacitracin Ophthalmic Ointment: 0574-4022-35.
  • Sulfacetamide Sodium Ophthalmic Ointment: 0574-4190-35.
  • Puralube Ophthalmic Ointment: 0574-4025-35 and 0574-4025-20.

What to do?

Consumers with questions about this recall should contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471 or emailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5 p.m. ET.

If you’ve experienced any problems that may be related to taking or using the products, Altaire recommends contacting your doctor.

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