Users of Apotex’s Brimonidine Tartrate Ophthalmic Solution, Pharmedica’s Purely Soothing eye drop brand, and Teva Pharmaceuticals’ Clear Eyes eye drops should be aware these products have been voluntarily recalled due to potential contamination leading to the risk of eye infection or blindness. The FDA advises people to discontinue use immediately and return the drops to where they bought them.*

Apotex recall

On March 1, 2023, Florida-based Apotex announced a voluntary recall of six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. The move was made “out of an abundance of caution” against “potential lack of sterility” from cracked bottle caps. “There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.”

Brimonidine Tartrate Ophthalmic Solution is intended to reduce elevated eye pressure in people with open-angle glaucoma and ocular hypertension. The six lots of recalled products listed below can be identified by the NDC numbers on the product label and packaging. Product packaging photos can be seen at the bottom of the announcement.

• TJ9848
• TJ9849
• TK0258
• TK5341
• TK0261
• TK0262

People with these lots should contact their pharmacy and healthcare provider immediately, and return their product to Inmar Rx Solutions at 1-855-275-1273. The company will send a return packet and Recall Stock Response Form.

• Consumers should report any possibly related issues to their healthcare provider.
• Any adverse events can be reported to the FDA’s MedWatch Adverse Event program.
• Consumers can email questions to Apotex at UScustomerservice@Apotex.com.

Pharmedica recall

On March 3, 2023, Arizona-based Pharmedica announced a voluntary recall of two lots of 15% MSM eye drops under the brand name Purely Soothing. The company also did this for possible “non-sterility,” though no known customer complaints of adverse events or illness have been reported.

In a statement of risk, Pharmedica said, “Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.” The eye drop is an anti-inflammatory for eye irritation symptoms and/or eye swelling.

• The eye drop is packaged in white, cylindrical bottles with eye dropper caps that have white lids. 
• LOT numbers: 2203PS01, 1 oz, UPC 7 31034 91379 9; and 1808051, ½ oz, UPC 7 31034 91382 9. 
• Product packaging photos can be found at the bottom of the announcement.

Again, Pharmedica advises consumers to immediately desist from using the product and return it to where it was purchased. 

• Consumers should report any possibly related issues to their healthcare provider.
• Any adverse events can be reported to the FDA’s MedWatch Adverse Event program.
• Consumers can email questions to Pharmedica at osm@pharmedicausa.com.

Teva Pharmaceuticals recall

Five (5) lots of Clear Eyes, Once Daily, Eye Allergy Itch Relief drops have been pulled by Teva Pharmaceuticals. Initiated on February 23, 2023, the recall of 715,682 bottles was spurred by a failed impurities test. Lot numbers are:

• 114349, expiration 05/2023
• 117396, expiration 09/2023
• 120128, expiration 11/2023
• 114371, expiration 06/2023
• 123781, expiration 02/2024

People with Clear Eyes are instructed to return them to their place of purchase for a full refund.

• Consumers should report any possibly related issues to their healthcare provider.
• Any adverse events can be reported to the FDA’s MedWatch Adverse Event program.
• Consumers can email Teva their questions at DrugInfo@tevapharm.com.

Succession of recalls

These latest recalls follow two other recent eye drop recalls. 

• The first was Ezricare Artificial Tears, recalled by Global Pharma Healthcare in January. The drops were linked to a cluster of infections with Pseudomonas aeruginosa bacterium in at least 11 states, causing dozens of injuries and disorders including permanent blindness, with at least three deaths in the U.S. 
• In February, the same company also recalled its popular Delsam Pharma’s Artificial Eye Ointment over possible microbial contamination.

Global Pharma Healthcare, based in India, is now banned from exporting its products to the U.S. after failing to comply with proper manufacturing guidelines.

*Bradford, B. (2023, March 8). FDA Recalls Two More Eye Drop Products After Emergency Recall in February. Health Digest. https://www.msn.com/en-us/health/health-news/fda-recalls-two-more-eye-drop-products-after-emergency-recall-in-february/ar-AA18niw4