Altaire Pharmaceuticals has voluntarily recalled 150 lots of 23 ophthalmic products due to the potential for nonsterility. The eye drops and ointments were manufactured and labeled exclusively for Walgreens, Walmart, and Perrigo, and sold over the counter or by prescription in those retail stores.
The recall is a precautionary response to quality assurance concerns at the manufacturing facility, Altaire noted. No injuries have been reported and all recalled products have passed sterility testing.
Stores have been advised to return all affected units, and patients should immediately discontinue use of the following products.
Lubricant Eye Drops Moisturizing, 15 mL
1 lot; NDC: 0363-0185-13
Lubricant Eye Drops Moisturizing Twin Pack, 2 x 15 mL
1 lot; NDC: 0363-0185-49
Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, 3.5 gm
1 lot; NDC: 0363-7500-50
Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, 15 mL
2 lots; NDC: 0363-0193-13
Lubricant Eye Ointment PF Soothing, 3.5 gm
1 lot; NDC: 0363-0191-50
Equate Restore Tears Lubricant Eye Drops Twin Pack, 2 x 15 mL
4 lots; NDC: 49035-189-49
Equate Eye Allergy Relief Drops, 15 mL
15 lots; NDC: 49035-887-13
Equate Sterile Lubricant Stye Ointment, 3.5 gm
8 lots; NDC: 49035-875-50
Equate Comfort Gel Lubricant Eye Gel Twin Pack, 2 x 15 mL
6 lots; NDC: 49035-197-49
Equate Restore PM Nighttime Lubricant Eye Ointment, 3.5 gm
18 lots; NDC: 49035-191-50
Equate Night & Day Restore Tears Lubricant Eye Pack, 3.5g and 15mL
4 lots; NDC: 49035-883-59
Equate Support Advanced Twin Pack, 2 x 15 mL
2 lots; NDC: 49035-885-49
Equate Support Advanced Lubricating Eye Drops Dose Preservative Free, 25 count (0.6 mL fill)
7 lots; NDC: 49035-882-54
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL
4 lots; NDC: 49035-882-52
Equate Support Moisture Lubricant Eye Drops, 10 mL
5 lots; NDC: 49035-145-10
Support Harmony Lubricant Eye Drops, 10 mL
1 lot; NDC: 49035-145-10
Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment, 3.5 gm
2 lots; NDC: 0574-4250-35
NEO-POLY DEX (Neomycin, Polymixin B and Dexamethasone) Ophthalmic Ointment, 3.5 gm
28 lots; NDC: 0574-4160-35
NEO-POLYCIN HC (Neomycin, Polymixin B, Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment, 3.5 gm
4 lots; NDC: 0574-4144-35
POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment, 3.5 gm
12 lots; NDC: 0574-4021-35
Bacitracin Ophthalmic Ointment, 3.5 gm
11 lots; NDC: 0574-4022-35
Sulfacetamide Sodium Ophthalmic Ointment, 3.5 gm
2 lots; NDC: 0574-4190-35
Puralube Ophthalmic Ointment, 1-3.5 gm
11 lots; NDC 0574-4025-35 and 0574-4025-20
Questions regarding this warning should be directed to Altaire Pharmaceuticals Inc. at 1-800-258-2471 or by email at otcdruggist@aol.comfrom 8:30 am to 5 pm ET, Monday through Friday.
To date, the US Food and Drug Administration (FDA) is not aware of any reports of illness associated with the use of the recalled products.
