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Artificial Tears Recalled by FDA

Monday, January 02, 2023

Nashua Eye strives to keep patients and the communitiy current on public health issues related to eye care. A number of artificial tear products have been recalled due to contamination or poor manufacturing conditions. 

Artificial tears play a common role in the treatment of dry eye. Typically, lubricating drops are extremely safe when used and stored correctly.

Beginning in 2023, Psuedomononas aeruginosa, a bacteria, caused a number of serious eye infections and vision loss, as well as critical illness. The bacteria strain could be traced to articial tear contamination. The tainted products were manuctured at facilities in India. These artificial tear products were recalled by the FDA. Since then, non-sterile manufacturing conditions have been cited as reason for numerous other eye drop product recalls. 

Below is a list of artifical tears recalled by the FDA as of December, 2023:

 

EzriCare Artificial Tears Lubricant Eye Drops, NDC 79503-0101-15 and UPC 3 79503 10115 7.

Delsam Pharma Artificial Tears Lubricant Eye Drops, NDC 72570-121-15 and UPC 3 72570 12115 8.

Delsam Pharma Artificial Eye Ointment, NDC 72570-122-35 and UPC code 3 72570 12235 3.

Clear Eyes Once Daily, Eye Allergy Itch Relief: Lot 114349, Lot 117396, Lot 0120128, Lot 114371, and Lot 123781.

Purely Soothing 15% MSM Drops, LOT#: 2203PS01, UPC 7 31034 91379 9; and LOT#: 1808051, UPC 7 31034 91382 9.

Brimonidine Tartrate Ophthalmic Solution, 0.15%, NDC numbers 60505-0564-1, 60505-0564-2 and 60505-0564-3.

Dr. Berne’s MSM Drops 5% Solution, Lot# 6786.

LightEyez MSM Eye Drops-Eye Repair, NDC number not provided.

CVS Health Lubricant Eye Drops 15 ml (single pack), NDC number 76168-702-15.

CVS Health Lubricant Eye Drops 15 ml (twin pack), NDC number 76168-702-30.

CVS Health Lubricant Gel Drops 15 ml (single pack), NDC number 76168-704-15.

CVS Health Lubricant Gel Drops 15 ml (twin pack), NDC number 76168-704-30.

CVS Health Multi-Action Relief Drops 15 ml, NDC number 76168-706-15.

CVS Health Lubricating Gel drops 10 ml, NDC number 76168-712-10.

CVS Health Lubricant Eye Drops 10 ml (single pack), NDC number 76168-714-10.

CVS Health Lubricant Eye Drops 10 ml (twin pack), NDC number 76168-714-20.

CVS Health Mild Moderate Lubricating Eye Drops 15 ml (single pack), NDC number 76168-711-15.

Rugby Lubricating Tears Eye Drops 15 ml, NDC number 0536-1282-94.

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 ml, NDC number 0536-1325-94.

Leader Dry Eye Relief 15 ml, NDC number 70000-0089-1.

Leader Lubricant Eye Drops 15 ml (single pack), NDC number 70000-0090-1.

Leader Dry Eye Relief 10 ml, NDC number 70000-0088-1.

Leader Eye Irritation Relief 15 ml, NDC number 70000-0087-1.

Rite Aid Lubricant Eye Drops 15 ml (twin pack), NDC number 11822-9707-5.

Rite Aid Lubricant Eye Drops 10 ml (twin pack), NDC number 11822-4811-3.

Rite Aid Gentle Lubricant Gel Eye Drops 15 ml, NDC number not provided.

Rite Aid Lubricant Gel Drops 15 ml, NDC number 11822-9706-5.

Rite Aid Lubricating Gel Drops 10 ml, NDC number 11822-4540-3.

Rite Aid Multi-Action Relief Drops 15 ml, NDC number 11822-2254-3.

Target Up&Up High Performance Lubricant Eye Drops 15 ml, NDC number 11673-522-30.

Target Up&Up High Performance Lubricant Eye Drops 15 ml (single pack), NDC number 11673-522-15.

Target Up&Up Dry Eye Relief 15 ml, NDC number 76168-800-30.

Velocity Pharma LLC Lubricant Eye Drop 10 ml (triple pack), NDC number 76168-502-30.

Walmart Equate Hydration PF Lubricant Eye Drop 10 ml, NDC number 79903-168-01.

Leader Lubricant Eye Drops 15 ml (twin pack), NDC numbers 70000-0090-2 (carton) and 70000-0090-1 (bottle). 

 

 

 

 

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