Altaire Pharmaceuticals Inc. announced Wednesday that it has voluntarily recalled several of its eye drops and ointments due to sterility concerns.
The New York-based company said in a statement that it was initiating the voluntary recall due to "management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility."
The company said the administration of a "non-sterile product intended to be sterile" could result in serious and life-threatening infections or it could be fatal. The company said it has not received any reports of adverse effects.
The company said it was recalling over-the-counter products sold at Walmart that were shipped to the retailer on specific dates. The products include Equate Restore Tears Lubricant Eye Drops Twin Pack, Equate Eye Allergy Relief Drops, Equate Sterile Lubricant Stye Ointment, Equate Comfort Gel Lubricant Eye Gel Twin Pack, Equate Restore PM Nighttime Lubricant Eye Ointment, Equate Night & Day Restore Tears Lubricant Eye Pack, Equate Support Advanced Twin Pack, Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, Equate Support Advanced Lubricant Gel Drops, Equate Support Moisture Lubricant Eye Drops and Support Harmony Lubricant Eye Drops. Click here to see the full recall list and the lot numbers.
Altaire said it was recalling products sold at Walgreens including Lubricant Eye Drops Moisturizing, Lubricant Eye Drops Moisturizing Twin Pack, Sodium Chloride Ophthalmic Ointment 5 percent Hypertonicity Eye Ointment, Sodium Chloride Ophthalmic Solution, 5 percent Hypertonicity Eye Drops and Lubricant Eye Ointment PF Soothing. For a full list of the recalls and the lot numbers, click here.
The company said it also voluntarily recalled 59 lots of prescription ointments and 11 lots of Puralube Ophthalmic Ointment that were "manufactured and labeled exclusively for Perrigo Company PLC," according to the U.S. Food & Drug Administration. The products recalled included Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, NEO-POLY Dex, NEO-POLYCIN HC, POLYCIN, Bacitracin Ophthalmic Ointment, Sulfacetamide Sodium Ophthalmic Ointment and Puralube Ophthalmic Ointment, which is over the counter. Click here to see the full lot list.
The company said it has notified Walgreens, Perrigo and Walmart regarding the recalls. It has asked consumers to contact the company with questions and to see a doctor if they have "experienced any problems."
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