RECALL ALERT: Ointments, dry eye drops, and allergy drops (Walmart Equate brand)

Posted by Rebecca Petris on

ALERT:

As of July 17, there are ~120 different products under 14 brands that have been recalled. We are now referring everyone to The Dry Eye Foundation where all of the recall information has been consolidated and is being updated daily as needed.

Altaire Ophthalmic Product Recalls

 

Original blog post:


New ointment woes

Many people with dry eye have been adversely impacted by the shortages of ointments and gels after Allergan stopped producing Refresh PM and Lacri-Lube ointments in 2017. The demand domino effect has resulted in severe shortages of almost all brands from time to time over the past 18 months. I've been tracking that on a blog post since early 2018. 

Yesterday, this problem was compounded by a massive recall notice about Walmart's Equate brand drops and ointments produced by Altaire Pharmaceuticals. Among those recalled is Walmart's Equate Restore PM Nighttime Lubricant Eye Ointment.

Altaire's generic ointments - Walmart Equate, and ActivEyes - are, to the best of my knowledge, the only ointments left on the market that are almost identical to Refresh PM - that is, the same proportion of petrolatum and mineral oil. For this reason, many people have preferred them over competing "name brand" ointments, which all have more petrolatum. So this is a blow. I can only hope that Allergan will get their product back on the market when they say they will i.e. in the course of the summer. Meantime, for more information on alternatives, please refer to my blog here. Your doctor should be able to recommend a substitute if you cannot get what you need, and social media dry eye groups are helpful for finding what is or is not available locally.

What you should do

Please check the press release (for convenience, I have listed the affected products/lots below as well for the ointments) and check anything you have in your supplies against those lot numbers. If you find any matches, please follow the manufacturer's instructions, which say:

"Customers with questions regarding this recall can contact Altaire Pharmaceuticals Inc., by calling 1-800-258-2471, or e-mailing otcdruggist@aol.com Monday thru Friday from 8:30 a.m. to 5:00 p.m. ET.  Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product."

What the recall means (and doesn't)

It does NOT mean that there is something known to be wrong with actual products. Here is what they said:

"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."

It DOES mean that something is wrong with the standards in place at the time that the products in these lots were produced, resulting in potential for nonsterility:

"As a precautionary measure, Altaire is initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility."

Please check for these products 

The following products and lot numbers were included in the recall notice. PLEASE CHECK for these among your supplies and follow the instructions given by the manufacturer in the press release:

 Product Affected lots Expiration
Equate Restore PM Nighttime Lubricant Eye Ointment W-M itemt #551282425 NDC #49035-191-50 Size: 3.5g
SKG 8/21
SHK 8/21
SHJ 8/21
SEC 5/21
SCB 3/21
SBC 2/21
RLB 12/20
RBB 2/20
RHR 8/20
RFK 6/20
RAB 1/20
TAD 1/22
TAQ 1/22
TBI 2/22
TDB 4/22
QHE 8/19
QJD 10/19
SGE 7/21
Equate Sterile Lubricant Stye Ointment W-M #563031651 NDC #49035-875-50
SAJ
1/21
SFE 6/21
SIA 9/21
RIE 9/20
REH 5/20
RAD 1/20
TAH 1/22
TDD 4/22
Equate Restore Tears Lubricant Eye Drops Twin Pack W-M # 552374320 NDC #49035-189-49 Size 2x15mL 4 lots expiring between 7/2019 and 2/2021 Please see press release for details
Equate Eye Allergy Relief  Drops  W-M item #: 567371432  NDC #: 49035-887-13  Package Size: 15 mL
15 lots expiring between 3/2020 and 5/2021
Please see press release for details
Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319 NDC #: 49035-197-49   Package Size: 2 x 15 mL
6 lots expiring between 8/2019 and 2/2021
Please see press release for details
Equate Night & Day Restore Tears Lubricant Eye Pack W-M #567368000 NDC #49035-883-59 Sizes 3.5g and 15mL 4 lots expiring between 2/2020 and 2/2021
Please see press release for details
Equate Support Advanced Twin Pack  W-M item #: 567371433 NDC #: 49035-885-49  Package Size: 2 x 15 mL
2 lots expiring between 1/2022 and 5/2022
Please see press release for details
Equate Support Advanced Lubricant Eye Drops Dose Preservative Free W-M #563031654 NDC #49035-882-54 Size 25 ct 7 lots expiring between 9/2019 and 2/2021
Please see press release for details
Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free W-M #567367998 NDC #49035-882-52 Size 7.5mL 4 lots expiring between 5/2020 and 4/2021
Please see press release for details
Equate Support Moisture Lubricant Eye Drops  W-M item #: 553503238 NDC #:  49035-145-10   Package Size:10 mL
5 lots expiring between 12/2019 and 1/2021
Please see press release for details
Support Harmony Lubricant Eye Drops  W-M item #: 553503238   NDC #:  49035-145-10   Package Size: 10 mL (discontinued Jan 2018)
Lot 17290 expiring 9/2019
Please see press release for details

Is Activeyes ointment affected?

The Activeyes ointment that we sell at the dry eye shop (which we brought in specifically because of the Refresh PM shortage) is made by Altaire. We have not received any notice of any recall affecting this product, but we have discontinued it pre-emptively, at least until we can verify status. If you have any concerns, please contact us. 

Related recalls

6 prescription ointments plus Puralube OTC
5 Walgreens products (drops, ointments, sodium chloride drops/ointment)


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5 comments

  • Oh how I wish our story was not legit. To the present my husband has had three cornea transplants in his left eye, been on numerous eye drops both prescription and non. To date I have proof of 5 non and prescription eye drops he was on that is currently under recall. My husband was a truck driver and one morning stopped in walmart because he thought he was getting a stye and purchased the stye ointment back in October 2018. In less than a week his whole cornea turned white. After many cultures we found out he had fusarium which is a fungus. 3 days after Thanksgiving his cornea ruptured and we had to have emergency cornea transplant. After the surgery some how the drops and creams used in the surgery room ended up on our nightstand in recovery so I put them in our bag. 2 weeks later we were in emergency surgery again because this cornea was melting. We were able to keep the second one till January 14th and have had the 3rd one since then. My sweet husband is still blind in his left eye. Remember the drops I put in my bag? They are under recall also. We are currently in the process of having our dr send off a sample of the original stye medication to test for fungus considering the products being recalled are for being made in non sterile conditions which means unclean. My husbands first symptoms were red and irritated light sensitivity and pain after using the stye medication. Please anyone use the FDA med watch voice your concerns. Our life was a living hell. We have managed but we list our trucking business to the unknown.

    Christi on
  • I have been using Equate restore tear drops for years. I began having problems with my eye after using a new dispenser of drops purchased at Walmart.
    About 2 weeks ago my right eye became red, swollen, sensitive to light and felt as though there was a foreign object in my eye.
    I went to an Eye Doctor who placed me on Neomycin and Polymyxin b Sulfaesand Dexamethasone.
    I am still having problems.

    Steve Muti on
  • Christi makes a very good point that when adverse events happen, they should be reported via the FDA website. Here is a link:

    https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1

    Christi, I’m surprised at what you said as Altaire has stated there have been NO adverse event reports related to their drugs. I also looked them up in MAUDE some time ago and did not find any adverse event reports. If your post was legit, I hope you will respond and clarify.

    “Skeptical”, I have deleted your very rude and inappropriate post. Christi said nothing about suing nor about any pre-existing conditions.

    Rebecca Petris on
  • I hope anyone who has been effected speaks up! My husband is blind in his left eye possibly from using multiple of the recalled products. Please if you think you have been affected go on FDA medwatch and fill out the form.

    Christi on
  • Hello,
    When will the Equate Comfort Gel dropa be available ? I really need them!
    Barbara.baker07@yahoo.com

    Barbara B3 on

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