How FDA drug recalls work
Possible sterility issues caused a massive recall of eye ointments, including 91 lots of over-the-counter ointments sold at Walmart, Walgreens and elsewhere.
Another 59 lots of prescription eye ointments made by Altaire Pharmaceuticals for Perrigo Company were included in Wednesday’s announcements. In the company-written, FDA-posted notice of the Perrigo recalls, Altaire said the recalls were, “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”
While the notice said none of the products have tested outside the sterility guidelines, the risk is “administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”
Of the over-the-counter eye ointments in this recall, 74 lots were sold as Walmart’s store brand, Equate:
Restore Tears Lubricant Eye Drops, Twin Pack; Eye Allergy Relief Drops; Sterile Lubricant Stye Ointment; Comfort Gel Lubricant Eye Gel, Twin Pack; Restore PM Nighttime Lubricant Eye Ointment; Night & Day Restore Tears Lubricant Eye Pack; Equate Support Advanced, Twin Pack; Supprot advanced Lubricating Eye Drops Dose Preservative Free; Support Advanced Lubricant Gel Drops Multi-Dose Preservactive Free; Support Moisture Lubricant Eye Drops; and Support Harmony Lubricant Eye Drops.
If you use any of the above Equate products, click here to see if your ointment was in a recalled lot.
Another six lots of eye ointments were sold as Walgreens store brand:
Lubricant Eye Drops Moisturizing, lot No. 19095; Lubricant Eye Drops Moisturizing Twin Pack, lot No. 19095; Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, lot No. TCI; Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, lot Nos. 19105 and 19050; and Lubricant Eye Ointment PF Soothing, lot No. TDB.
And 11 over-the-counter ointments made for Perrigo were sold as Puralube Ophthalmic Ointment. The lot Nos. for those were RJH, SCC, SGA, SGH, SHH, SLL and TAC in the 3.5gm tubes; and RKM, SGA, SIF and SKE in the 1gm tubes.
The 59 lots of prescription ointments are Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment; NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment; NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment; POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment; Bacitracin Ophthalmic Ointment; and Sulfacetamide Sodium Ophthalmic Ointment.
The recalled prescription drug lot list can be found here.
Anyone with questions on these recalls can contact Altaire at 800-258-2471 or firstname.lastname@example.org.