Health & Fitness

More eye meds recalled on sterility concerns that hit Walmart, Walgreens, CVS brands

How FDA drug recalls work

The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.
Up Next
The U.S. Food and Drug Administration regulates the safety of drugs, but sometimes a problem arises that triggers a recall. Here's how the recall process works and what you should do if a medicine you use is recalled.

The sterility uncertainty at an Altaire Pharmaceuticals facility that spurred the recalls of numerous prescription and over-the-counter ophthalmic ointments swept up several more brands this week, including staple Clear Eyes.

Target joins Walmart, Walgreens and CVS as major chains with store brands recalled.

Though Altaire says in its FDA-posted recall notice that none of the finished products have tested outside the sterility boundaries, it’s making the voluntary recall after “management concerns” about quality control of “critical systems” in the facility.

“The FDA has determined these issues indicate a lack of sterility assurance,” Altaire writes. “Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.”

This week’s recalls:

Accutome: Accu-WASH, 4 fluid ounces, lot Nos. 16250; 17088; 17307; 17323; 18014; 18228; 18261; and 19119.

ActivEyes: Nighttime Lub Eye Ointment Preservative Free, 3.5 g; Altachlore Ointment, 3.5 g; Altachlore Solution, 15 ml; Altalube Ointment, 3.5 g; Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF, 7.5 ml; Preservative Free Multi-Dose Lubricant Drops Sensitive PF, 7.5 ml; and Lubricant Eye Ointment Preservative Free, 3.5 g.

For the lot numbers recalled, click here.

Altaire: Altacaine Solution, 15 ml; Ciprofloxacin HCl Ophthalmic Solution 0.3%, 2.5 ml, 5 ml, 10 ml; Diclofenac Sodium Solution 1%, 2.5 ml and 5 ml; Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution, 5 ml; Eye Wash, 15 ml, 1 fluid ounces, 4 fluid ounces; Goniotaire, 15 ml; Homatropaire, 5 ml; Ofloxacin 0.3% Ophthalmic Solution, 5 ml;

For the lot numbers recalled, click here.

Clear Eyes: Redness Relief, 15 ml and 30 ml; Redness Relief (Handy Pocket Pal), 0.2 fluid ounces; Redness Relief (Little Drug) 0.2 fluid ounces; Redness Relief (Select Corp), 0.2 fluid ounces.

For the lot numbers recalled, click here.

FreshKote: Lubricant Eye Drops, 15 ml, lot No. 18095.

Grandall: Colirio Ojo De Aguila Eye Drops, 15 ml; Colirio Oftal-Mycin Redness Relief Eye Drops, 15 ml; Oftal-Mycin Ophthalmic Ointment, 3.5 g.

For the lot numbers recalled, click here.

Nano Tears: HA PF Multi Dose Lubricant Gel Drops, 10 ml; MO Clear Emollient Mineral Oil Lipids, 10 ml; MXP Forte Clear Emollient Lubricant Gel Drops, 10 ml and Twin Pack, two 10 ml tubes; TF Clear Emollient Tear Film Replenishment Essential Lipids, 7.5 ml; MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free, 32-count, 0.6 ml; TF Clear Emollient Lubricant Gel Drops Preservative Free, 32-count, 0.6 ml; TF Clear Emollient Lubricant Gel Drops, 15 ml and Twin Pack, two 15 ml tubes; XP Clear Emollient Lubricant Gel Drops, 10 ml and Twin Pack, two 10 ml tubes.

For the lot numbers recalled, click here.

Natural Opthalmics, all in 15ml tubes: Ortho-K Thick Comfort Gel, 15 ml; Women’s Tear Stimulation Dry Eye Drops; Ortho-K Thin Eye Drops; Tear Stimulation Forte Dry Eye Drops; Cataract Eye Drops with Cineraria; and Allergy Desensitization Eye Drops.

For the lot numbers recalled, click here.

OCuSOFT, some prescription and some over-the-counter (or over the Internet): Homatropine Hydrobromide Ophthalmic Solution 5%, 5 ml; Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5%, 15ml; Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution, 15ml; Tetravisc Forte, 5 ml and 12 pieces, 0.6 ml per piece; Tetravisc, 5 ml and 12 pieces, 0.6ml per piece; Flucaine, 5 ml; Eye Wash, 1 fluid ounce and 4 fluid ounces; Tears Again Lubricant Eye Drops, 15 ml and 30 ml; Tears Again Lubricant Eye Ointment Nighttime Relief, 3.5 g; retaine NaCl Ophthalmic Ointment, 3.5 g and 15 ml.

For the lot numbers recalled, click here.

TRP: Blur Relief, 15ml; Stye Relief, 4g; Pink Eye Relief, 10ml; and TRP/Target up & up intensive relief lubricating eye drop, 10ml.

For the lot numbers recalled, click here.

Those with questions can call Altaire at 1-800-258-2471, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time, or email otcdruggist@aol.com.

Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
  Comments