Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Reason Lack of Assurance of Sterility
Brimonidine Tartrate Opthalmic Solution 0.2%
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
What was recalled
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
- Recalling firm
- Somerset Therapeutics LLC
- NDC code
- 70069-231-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1373-2020
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Brimonidine recalls
See all
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II · Moderate risk Ongoing
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Brimonidine Tartrate Ophthalmic Solution 0.15%
Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Class III · Low risk Terminated
Brimonidine Tartrate Opthalmic Solution 0.2%
Reason Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
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