(Update: More FDA recalls) Bacterial Outbreak Linked to EzriCare & Delsam Pharma Eyedrops

[Arcadia]

https://www.webmd.com/eye-health/news/20230201/bacterial-outbreak-linked-ezricare-eyedrops-cdc
“Feb. 1, 2023 -- A bacterial outbreak linked to eyedrops has caused one death and sickened at least 50 people in 11 states, the CDC says. Some patients have been hospitalized and some are now permanently blind.

“Recent epidemiology and laboratory evidence link these infections to use of EzriCare Artificial Tears,” the CDC said in a statement.

People should discontinue using EzriCare Artificial Tears, the agency advised. The over-the-counter product is available from retailers such as Walmart.”

https://www.aao.org/Assets/3a187c94-7889-42e8-84a1-6b2e88e7d374/638098403609770000/epix-multistate-pseudomonas-investigation-20jan2023-pdf?inline=1
“The Centers for Disease Control and Prevention (CDC) is investigating a multistate cluster of Verona Integron‐mediated Metallo‐β‐lactamase (VIM)‐ and Guiana‐Extended Spectrum‐β‐Lactamase (GES)‐ producing carbapenem‐resistant Pseudomonas aeruginosa (VIM‐GES‐CRPA) associated with multiple different infection types, including eye infections. Recent epidemiology and laboratory evidence link these infections to use of EzriCare Artificial Tears.
From May 17, 2022, to January 19, 2023, CDC, in partnership with state and local health departments, identified 56 isolates from 50 case patients from 11 states (CA, CO, CT, FL, NJ, NM, NY, NV, TX, UT, WA) with VIM‐GES‐CRPA; 38 cases are part of 4 facility clusters. Dates of specimen collection are from May to December 2022. Isolates have been identified from clinical cultures of cornea (10), sputum or bronchial wash (11), urine (6), other nonsterile sources (4), and blood (2), and from rectal swabs (23) collected for surveillance. These specimens were collected in both outpatient and inpatient healthcare settings. Patient outcomes include permanent vision loss resulting from ocular infection, hospitalization, and death of one patient with bloodstream infection.”

Edited March 17, 2023 by Arcadia

[Hen]

this is scary, thank you for sharing!  I have dry eye...I don't use that brand though. wow, I've never thought of eye drops being a potential hazard! 

[TravelingChris]

4 hours ago, Hen said:

this is scary, thank you for sharing!  I have dry eye...I don't use that brand though. wow, I've never thought of eye drops being a potential hazard! 

It is why as a Sjogren's syndrome patient, I was always told to use individaul drops, not bottles.  

[Serenade]

Thank you for posting this.  I don't use that specific product, but I use others, and the dry-eye is especially bad at this time of year.

[Arcadia]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-artificial-tears-lubricant-eye-drops-due
“Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and are placed in a carton box Ezricare NDC 79503-0101-15, UPC 3 79503 10115 7; Delsam Pharma’s NDC 72570-121-15, UPC -72570-0121-15. It can be identified by the photos below. The product was distributed Nationwide in the USA over the Internet.

…

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC - by phone: 1-518-738-7602 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm EST; or DELSAM Pharma LLC by phone: 1-866-826-1309 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Product Photos

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[popmom]

On 2/3/2023 at 4:04 AM, TravelingChris said:

It is why as a Sjogren's syndrome patient, I was always told to use individaul drops, not bottles.  

I was told it was because of the preservatives--the bigger bottles have preservatives that are supposed to kill that stuff (benzalkonium chloride BAK). BAK is harmful to the eye if used frequently like we do. Hence the tiny preservative free vials.

 

[popmom]

I'm glad this got bumped! I hope it's just limited to this one brand. 

[stephanier.1765]

6 hours ago, popmom said:

I'm glad this got bumped! I hope it's just limited to this one brand. 

Me too because I need to order more eyedrops but I'm too scared of them all to actually do it.

[Arcadia]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/global-pharma-healthcare-issues-voluntary-nationwide-recall-delsam-pharma-artificial-eye-ointment
“FOR IMMEDIATE RELEASE - February 23, 2023, Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised.

… The product can be identified by the photos provided below. The product was distributed nationwide in the United States, and by Delsam through internet retail sites. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3.

Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers, and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers with questions regarding this recall can contact the distributor Delsam Pharma, LLC by phone at 1-866-826-1306 or by e-mail at delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST.

Product Photos

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[Arcadia]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/apotex-corp-issues-voluntary-nationwide-recall-brimonidine-tartrate-ophthalmic-solution-015-due
“March 01, 2023 – Weston, Florida, Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.

… These lots were distributed nationwide in the USA between April 05, 2022 to February 22, 2023.

Product	Strength	Pack Size	NDC #	UPC Code on Carton	UPC Code on Bottle	Lot #	Expiry Date
Brimonidine Tartrate Ophthalmic Solution	0.15%	5 mL	60505-0564-1	360505056415	(01)0(03) 60505056415	TJ9848	02/2024
						TJ9849
						TK0258	04/2024
						TK5341
		10 mL	60505-0564-2	360505056422	(01)0(03) 60505056422	TK0261
		15 mL	60505-0564-3	360505056439	(01)0(03) 60505056439	TK0262

Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight) and is arranging for return of all recalled product.

Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy. They should immediately contact their health care provider for medical advice and return the identified lots to Inmar Rx Solutions by contacting at the phone number provided in this press release.”

[Arcadia]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/pharmedica-usa-llc-issues-voluntary-worldwide-recall-purely-soothing-15-msm-drops-due-non-sterility
“Phoenix, Arizona, USA; Pharmedica USA LLC is voluntarily recalling two lots of Purely Soothing, 15% MSM Drops to the consumer level. This product is being recalled due to non-sterility.

Risk Statement: Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.

To date, Pharmedica USA LLC has not received any reports of adverse events or illness related to this recalled product.

….

The eye drops (LOT#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT#: 1808051, ½ oz, UPC 7 31034 91382 9) have eye dropper caps and white lids. The product can be identified by the labels below.

Pharmedica USA LLC is advising customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distributing/return to Pharmedica USA LLC immediately or confirm that the product has been disposed of with proper verification.

Consumers with questions regarding this recall can contact Pharmedica USA LLC by phone number at +1 (623) 698 - 1752 or e-mail address at osm@pharmedicausa.comMonday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ).. “