Product recall alert: Eye drops, gels and ointments

last updated 7/24/2019

recalls

In a nutshell

  • 14 brands, 120 products, 619 lots affected

  • Manufacture dates range from 2016 to 2019

  • OTC product types include: lubricant eye drops and gels, allergy drops, redness relievers, lubricating ointments, sodium chloride ointments and solutions, and eye washes

  • Rx product types include antibiotic, steroid, NSAID, anaesthetic, fluorescein, anticholinergic, and demulcent drops as well as some ointments

  • All recalls have been issued by a single manufacture, Altaire Pharmaceuticals

  • UPDATE: There is confusion over products and lot numbers due to corrections being issued to distributors with no public notification. We have incorporated all the corrections we know of to Walmart and Ocusoft products in the listings below as well as the spreadsheets.

Resources

  • FDA “Recalls, Market Withdrawals, & Safety Alerts” page (search on Altaire) - but please note that the FDA’s information is not comprehensive. More products and lots have been recalled than they are listing.

  • Product list below (scroll down) for ease of reference

    • We have consolidated the product lists below for ease of page searching on a brand or product - since the FDA recalls are spread across 8 different notices some of which do not include recognizable brand names in the subject lines

    • Includes links to recall announcements with more details including lot numbers to check for

  • Google sheet with all product and lot details

  • Google sheet with summary information by brand

What’s happening?

Starting on July 3, 2019, Altaire Pharmaceuticals began announcing a series of recall notices for a larger number of OTC and Rx eye drops, gels and ointments. These announcements (with one exception due to what we believe to be an FDA error) are all listed on the FDA’s “recalls, market withdrawals and safety alerts” website.

This is an emerging situation and some aspects are bound to be confusing for consumers.

  • We are told that there have been no adverse events and no sterility test failures, but that all the affected products have “potential for non-sterility” or a “lack of sterility assurance” which can lead to “serious and potentially life-threatening infections or death”

  • However, the manufacturer’s recalls are “retail-level”, which means the retailers and distributors simply have to send their stock back to the manufacture and none of them have to notify consumers.

  • The major drugstore chains appear to have issued their own voluntary consumer-level recalls, but not all distributors of affected products have done so.

  • There is no single point of information for this manufacturer’s recalls on the FDA’s site, making it much harder for both physicians and consumers to find information they may need. This is why we are collecting information about it here.

What should I do?

We encourage ALL consumers to:

  • Check your supplies for products listed here or at the links provided below.

  • Check the lot numbers and expirations against the lot information in the links.

  • Contact your eye doctor.

  • Please do not discontinue a prescribed medication without discussing it with your doctor.

Your eye doctor is your best resource in this situation!

Which brands are being recalled?

As of this writing (July 21, 2019) there have been recalls affecting the following:

  • Walmart's Equate brand (11 products, 87 lots of OTC ointments and drops)

  • Walgreens brand (5 products, 6 lots of OTC ointments and drops)

  • Perrigo brand (8 products, 70 lots of OTC and Rx ointments)

  • CVS brand (30 products, 189 lots of OTC drops and ointments)

  • Altaire/Nano Tears brand (11 products, 20 lots of OTC drops)

  • Altaire/ActivEyes (7 products, 18 lots of OTC drops and ointments and Rx solutions and ointments)

  • Altaire (13 products, 85 lots of OTC eyewashes and Rx solutions)

  • OCuSOFT (15 products, 71 lots of OTC drops, ointments and eyewashes and Rx solutions)

  • Natural Ophthalmics (6 products, 14 lots of OTC drops)

  • TRP/Target Up & Up (4 products, 14 lots of OTC drops and ointments)

  • Accutome (1 product, 8 lots of OTC eyewash)

  • Focus Laboratories (1 product, 1 lot of a discontinued eye drop)

  • Grandall (3 products, 8 lots of OTC drops)

  • Prestige/Clear Eyes (5 products, 28 lots of OTC drops)

Details

Why were they recalled?

“Potential for nonsterility” or “Due to a lack of sterility assurance” are what is listed on each of the eight announcements on FDA recall site.

The language varies slightly from one announcement to another but most of them seem to all include either the following or something similar:

  • “To date, Altaire has received no reports of adverse events, nor has Altaire obtained any out of specifications results including Sterility testing, for the products.”

  • “As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility. The FDA has determined these issues indicate a lack of sterility assurance.”

  • “This recall is being carried out to the retail level and is only for the specific lots listed”

  • “Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

product list

Last updated 7/18/2019

This list is provided for your convenience. Accuracy and currency cannot be guaranteed. PLEASE USE THE LINKS TO THE FDA PAGES.

1. Walmart Equate

See original announcement with 11 products (includes lot numbers). This is no longer available on the FDA site, but should be. The current FDA link says 7/3/19 but what it contains is a 7/15/19 correction to 6 of the 11 products (which Altaire issued corrections on due to numerous errors and typos in lot and NDC numbers). Unfortunately someone appears to have overridden the original with ONLY the list of corrections. Here is the Correction to original recall notice.

WE ARE INCLUDING ALL 11 PRODUCTS BELOW and in our spreadsheets - HAVING INCORPORATED THE CORRECTIONS, because we feel the FDA page is now omitting important information on some recalled Walmart products.

  • Equate Restore Tears Lubricant Eye Drops Twin Pack W-M item #: 552374320 NDC #: 49035-189-49 Package Size: 2 x 15 mL

  • Equate Eye Allergy Relief Drops W-M item #: 567371432 NDC #: 49035-887-13 Package Size: 15 mL

  • Equate Sterile Lubricant Stye Ointment W-M item #: 563031651 NDC #: 49035-875-50 Package Size: 3.5 gram

  • Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319 NDC #: 49035-197-49 Package Size: 2 x 15 mL

  • Equate Restore PM Nighttime Lubricant Eye Ointment W-M item #: 551282425 NDC #: 49035-191-50 Package Size: 3.5 gram

  • Equate Night & Day Restore Tears Lubricant Eye Pack W-M item #: 567368000 NDC #: 49035-883-59 Package Size: 3.5g and 15mL

  • Equate Support Advanced Twin Pack W-M item #: 567371433 NDC #: 49035-885-49 Package Size: 2 x 15 mL

  • Equate Support Advanced Lubricating Eye Drops Dose Preservative Free W-M item #: 563031654 NDC # 49035-882-54: Package Size: 25 count (0.6 mL fill)

  • Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M item #: 567367998 NDC #: 49035-882-52 Package Size: 7.5 mL

  • Equate Support Moisture Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size:10 mL

  • Support Harmony Lubricant Eye Drops W-M item #: 553503238 NDC #: 49035-145-10 Package Size: 10 mL (Note: Support Harmony packaging was discontinued in January 2018.)

2. Walgreens

See FDA link for list of lots affected

  • Lubricant Eye Drops Moisturizing Walgreens item #: 801483 NDC #: 0363-0185-13 Package Size: 15 mL

  • Lubricant Eye Drops Moisturizing Twin Pack Walgreens item #: 801477 NDC #: 0363-0185-49 Package Size: 2 x 15 mL

  • Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment Walgreens item #: 801482 NDC #: 0363-7500-50 Package Size: 3.5 gram

  • Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops Walgreens item #: 801402 NDC #: 0363-0193-13 Package Size: 15 mL

  • Lubricant Eye Ointment PF Soothing Walgreens item #: 801486 NDC #: 0363-0191-50 Package Size: 3.5 gram

3. Perrigo

See FDA link for list of lots affected

  • Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment NDC Number: 0574-4250-35 Package Size: 3.5 gm

  • NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment NDC Number: 0574-4160-35 Package Size: 3.5 gm

  • NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment NDC Number: 0574-4144-35 Package Size: 3.5 gm

  • POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment  NDC Number: 0574-4021-35 Package Size: 3.5 gm

  • Bacitracin Ophthalmic Ointment NDC Number: 0574-4022-35 Package Size:3.5 gm

  • Sulfacetamide Sodium Ophthalmic Ointment  NDC Number: 0574-4190-35 Package Size: 3.5 gm

  • Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product) NDC Number: 0574-4025-35 Package Size: 3.5 gm

  • Puralube Ophthalmic Ointment (Please note: Puralube is an OTC product) NDC Number: 0574-4025-20 Package Size: 1 gm

4. CVS

See FDA link for list of lots affected

  • CVS Health Natural Tears Lubricant Eye Drops Preservative Free Item#: 538397 Product Size: 0.6 mL x 32 ct

  • CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye Item#: 317916 Product Size: 15 mL

  • CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye Item#: 247887 Product Size: 30 mL

  • CVS Health Dry Eye Relief Eye Drops Item#: 317914 Product Size: 15 mL

  • CVS Health Dry Eye Relief Eye Drops Item#: 457802 Product Size: 30 mL

  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution Item#: 495334 Product Size: 0.6 mL x 60 ct

  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution Item#: 994883 Product Size: 0. 6 mL x 30 ct

  • CVS Health Preservative Free Lubricant Gel Drops Dry Eye Relief Item#: 634634 Product Size: 0.6 mL x 30

  • CVS Health Lubricating Gel Drops for Anytime Use Item#: 563420 Product Size: 10 mL

  • CVS Health Overnight Lubricating Eye Ointment Item#: 881532 Product Size: 3.5 gram

  • CVS Health Lubricant Eye Ointment Item#: 247881 Product Size: 3.5 gram

  • CVS Health Extra Strength Lubricant Gel Drops Item#: 799143 Product Size: 15 mL

  • CVS Health Extra Strength Lubricant Gel Drops Twin Pack Item#: 258587 Product Size: 2 x 15 mL

  • CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Item#: 895160 Product Size: 15 mL

  • CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack Item#: 994881 Product Size: 2 x 10 mL

  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution Item#: 495301 Product Size: 0.6 mL x 30ct

  • CVS Health Preservative Free Lubricant Eye Drops Sensitive Solution Item#: 457791 Product Size: 0.6 mL x 70ct

  • CVS Health Preservative Free Lubricant Eye Drops Advanced Relief Item#: 563442 Product Size: 0.6 mL x 30

  • CVS Health Lubricant Eye Drops Advanced Relief Item#: 563419 Product Size: 10 mL

  • CVS Health Fast Acting Lubricant Eye Drops Preservative Free Item#: 994882 Product Size: 0.6 mL x 24 ct

  • CVS Health Preservative Free Lubricant Eye Drops Fast Acting Item#: 258625 Product Size: 0.6 mL x 60 ct

  • CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief Item#: 799145 Product Size: 30 mL

  • CVS Health Multi-Action Relief Drops Item#: 694954 Product Size: 15 mL

  • CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Item#:968210 Product Size: 10 mL

  • CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack Item#: 495323 Product Size: 2 x 10 mL

  • CVS Health Maximum Redness Relief Eye Drops Item#: 994880 Product Size: 15 mL

  • CVS Health Redness Relief Item#: 317912 Product Size: 15 mL

  • CVS Health Redness Relief Item#: 457799 Product Size: 30 mL

  • CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief Item#: 563431 Product Size: 15 mL

  • CVS Health Lubricant Eye Ointment Sensitive Formula Item#: 247885 Product Size: 3.5 gram

5. NanoTears

See FDA link for list of lots affected

  • Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Preservative Free NDC#: 59390-147-56 Product Size: 0.6 mL x 32 ct.

  • Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free NDC#: 59390-141-56 Product Size: 0.6 mL x 32 ct.

  • NanoTears HA PF Multi Dose Lubricant Gel Drops NDC#: 59390-208-10 Product Size: 10 mL

  • Nano Tears MO Clear Emollient Mineral Oil Lipids NDC#: 59390- 145-10 Product Size: 10 mL

  • Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops NDC#: 59390-144-10 Product Size: 10 mL

  • Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack NDC#: 59390-144-51 Product Size: 2 x 10 mL

  • Nano Tears TF Clear Emollient Tear Film Replenishment Essential Lipids Preservative Free Multi-Dose NDC#: 59390-141-52 Product Size: 7.5 mL

  • Nano Tears TF Clear Emollient Lubricant Gel Drops Twin Pack NDC#: 59390-142-49 Product Size: 2 x 15 mL

  • Nano Tears TF Clear Emollient Lubricant Gel Drops NDC#: 59390-142-13 Product Size: 15 mL

  • Nano Tears XP Clear Emollient Lubricant Gel Drops twin pack NDC#: 59390-143-51 Product Size: 2 x 10 mL

  • Nano Tears XP Clear Emollient Lubricant Gel Drops NDC#: 59390-143-10 Product Size: 10 mL

6. ActivEyes

See FDA link for list of lots affected

  • ActivEyes Nighttime Lub Eye Ointment Preservative Free NDC#: 59390-190-50 Product Size: 3.5 g

  • ActivEyes Altachlore Ointment NDC#: 59390-184-50 Product Size: 3.5 gram

  • ActivEyes Altachlore Solution NDC#: 59390-183-13 Product Size: 15 mL

  • ActivEyes Altalube Ointment NDC#: 59390-198-50 Product Size: 3.5 gram

  • ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops Long Lasting PF NDC#: 59390-148-52 Product Size: 7.5 mL

  • ActivEyes Preservative Free Multi-Dose Lubricant Drops Sensitive PF NDC#: 59390-146-52 Product Size: 7.5 mL

  • ActivEyes Lubricant Eye Ointment Preservative Free NDC#: 59390-189-50 Product Size: 3.5 gram

7. Altaire

See FDA link for list of lots affected

  • Altaire Altacaine Solution NDC#: 59390-181-13 Product Size: 15 mL

  • Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% NDC#: 59390-217-02 Product Size: 2.5 mL

  • Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% NDC#: 59390-217-05 Product Size: 5 mL

  • Altaire Ciprofloxacin HCl Ophthalmic Solution 0.3% NDC#: 59390-217-10 Product Size: 10 mL

  • Altaire Diclofenac Sodium Solution 1% NDC#: 59390-149-02 Product Size: 2.5 mL

  • Altaire Diclofenac Sodium Solution 1% NDC#: 59390-149-05 Product Size: 5 mL

  • Altaire Fluorescein Sodium with Proparacaine HCl Ophthalmic Solution NDC#: 59390-205-05 Product Size: 5 mL

  • Altaire Eye Wash NDC#: 59390-175-13 Product Size: 15 mL

  • Altaire Eye Wash NDC#: 59390-175-18 Product Size: 1 Fl. Oz.

  • Altaire Eye Wash NDC#: 59390-175-35 Product Size: 4 Fl. Oz.

  • Altaire Goniotaire NDC#: 59390-182-13 Product Size: 15 mL

  • Altaire Homatropaire NDC#: 59390-192-05 Product Size: 5 mL

  • Altaire Ofloxacin 0.3% Ophthalmic Solution USP NDC#: 59390-140-05 Product Size: 5 mL

8. OCuSOFT

See FDA link for list of lots affected

  • OCuSOFT Homatropine Hydrobromide Ophthalmic Solution 5% NDC #: 54799-431-05 Product Size: 5 mL

  • OCuSOFT Tetcaine Hydrochloride Ophthalmic Solution USP, 0. 5% NDC #: 54799-502-15 Product Size: 15 mL

  • OCuSOFT Goniosoft Hypromellose 2.5% Ophthalmic Demulcent Solution NDC #: 54799-503-15 Product Size: 15 mL

  • OCuSOFT Tetravisc Forte NDC #: 54799-504-01 Product Size: 0.6 mL x 12 pcs

  • OCuSOFT Tetravisc Forte NDC #: 54799-504-05 Product Size: 5 mL

  • OCuSOFT Tetravisc NDC #: 54799-505-01 Product Size: 0.6 mL x 12 pcs

  • OCuSOFT Tetravisc NDC #: 54799-505-05 Product Size: 5 mL

  • OCuSOFT Flucaine NDC #: 54799-507-21 Product Size: 5 mL

  • OCuSOFT Eye Wash NDC #: 54799-565-01 Product Size: 1fl oz

  • OCuSOFT Eye Wash NDC #: 54799-565-59 Product Size: 4 fl oz

  • OCuSOFT Tears Again Lubricant Eye Drops NDC #: 54799-904-15 Product Size: 15 mL

  • OCuSOFT Tears Again Lubricant Eye Drops NDC #: 54799-904-30 Product Size: 30mL

  • OCuSOFT Tears Again Lubricant Eye Ointment Nighttime Relief NDC #: 54799-906-35 Product Size: 3.5g

  • OCuSOFT Retaine PM Lubricant Eye Ointment NDC 54799-894-35 Package size 3.5g (This is not on the FDA notice, but in a correction notice from Ocusoft they stated that Retaine PM and Tears Again ointments share lot numbers)

  • OCuSOFT retaine NaCl Ophthalmic Ointment SKU #: 777-3-76 Product Size: 3.5g

  • OCuSOFT retaine NaCl Ophthalmic Solution SKU #: 777-3-77 Product Size: 15mL

Please note that Ocusoft lid scrub products and Retaine brand lubricant drops are NOT subject to recall. We reached out to Ocusoft, who shared a statement to doctors which states: “Retaine® NACL (ointment and Solution) are the only Retaine® products affected and that Retaine® MGD® lubricating eyedrops, OCuSOFT® Lid Scrub® and the overwhelming bulk of OCuSOFT®’s products are not manufactured by Altaire and are not affected. While other respected companies have experienced recalls, we nevertheless again regret this inconvenience. We pride ourselves on customer service and will be happy to assist you with any questions you may have. “

9. Natural Ophthalmics

See FDA link for list of lots affected

  • Product Description: Natural Ophthalmics Ortho-K Thick Comfort Gel NDC#: 68770-143-15 Product Size: 15 mL

  • Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops NDC#: 68770-103-15 Product Size: 15 mL

  • Natural Ophthalmics Ortho-K Thin Eye Drops NDC#: 68770-144-15 Product Size: 15 mL

  • Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops NDC#: 68770-104-15 Product Size: 15 mL

  • Natural Ophthalmics Cataract Eye Drops with Cineraria NDC#: 68770-130-15 Product Size: 15 mL

  • Natural Ophthalmics Allergy Desensitization Eye Drops NDC#: 68770-120-15 Product Size: 15 mL

10. TRP/Target Up & Up

See FDA link for list of lots affected

  • TRP/ TARGET up & up intensive relief lubricating eye drop Item#: 31012 Product Size: 10 mL

  • TRP Blur Relief NDC#: 17312-002-11 Product Size: 15 mL

  • TRP Stye Relief NDC#: 17312-014-13 Product Size: 4 g

  • TRP Pink Eye Relief NDC#: 17312-013-15 Product Size: 10 mL

11. Accutome

See FDA link for list of lots affected

  • Accutome Accu-WASH NDC#:  63448-411-04 Product Size: 4 FL.OZ.

12. Focus Laboratories (FreshKote)

See FDA link for list of lots affected

  • FreshKote Lubricant Eye Drops NDC#:  15821-101-15 Product Size: 15 mL

Please note that the recalled lot is only the earlier, preserved version which was discontinued and replaced with FreshKote PF in late 2018. We reached out to Eyevance for clarification about the status of FreshKote PF. They said: “FRESHKOTE PF is NOT MANUFACTURED by Altaire. Eyevance Pharmaceuticals is proud of its FRESHKOTE PF franchise and the dedication the team has in providing patients a safe and effective product that maintains the highest level of quality standards. Eyevance has a robust supply of FRESHKOTE PF to supply patients and consumers that require a tear lubricant – that were previously on another tear. Eyevance is here to serve our doctors, patients, suppliers and partners.”

13. Grandall Distributing Co., Inc

See FDA link for list of lots affected

  • Grandall Colirio Ojo De Aguila Eye Drops Product Size: 15 mL

  • Grandall Colirio Oftal-Mycin Redness Relief Eye Drops Product Size: 15 mL

  • Grandall  Oftal-Mycin Ophthalmic Ointment Product Size:  3.5 g

14. Prestige Brands Inc. (Clear Eyes)

See FDA link for list of lots affected

  • Clear Eyes Redness Relief UPC#: 6-78112-25415-6 Product Size: 15 mL

  • Clear Eyes Redness Relief UPC#: 6-78112-25419-4 Product Size: 30 mL

  • Clear Eyes Redness Relief (Handy Pocket Pal) UPC#: 6-78112-15418-7 Product Size:  0.2 FL. Oz.

  • Clear Eyes Redness Relief (Little Drug) UPC#: 7-92554-70103-7 Product Size:  0.2 FL. Oz.

  • Clear Eyes Redness Relief (Select Corp) UPC#: 6-55708-01039-6 Product Size:  0.2 FL. Oz. 

Spreadsheet with details

We have a Google sheet including all the products, lot numbers and FDA links and will continue to update that as well as this page should anything change or should more products be recalled.

Rebecca Petris9 Comments