July 17, 2020
Somerset Therapeutics is recalling nearly two dozen lots of brimonidine tartrate ophthalmic solution 0.2% because of potential impurity issues. According to the July 15, 2020, US Food and Drug Administration (FDA) Enforcement Report, “there is a slow leaching process from the product label on the bottle, which may impact the product over the shelf life.”
The recall affects the following products, which were distributed throughout the United States:
- brimonidine tartrate ophthalmic solution 0.2%, 5-mL bottles (NDC 70069-231-01) from lots BRM11W9001, BRM11W9002, and BRM11W9003 (Exp. 11/20); BRM11W9004, BRM11W9005, and BRM11W9006 (Exp. 12/20); BRM11W9007, BRM11W9008, and BRM11W9009 (Exp. 3/21); BRM11W9010, BRM11W9011, BRM11W9012, and BRM11W9013 (Exp. 4/21); and BRM11W9014 and BRM11W9015 (Exp. 5/21);
- brimonidine tartrate ophthalmic solution 0.2%, 10-mL bottles (NDC 70069-232-01) from lots BRM12W9001 (Exp. 2020 [the FDA report does not specify the month]); BRM12W9002 and BRM12W9003 (Exp. 12/20); and BRM12W9004 (Exp. 4/21); and
- brimonidine tartrate ophthalmic solution 0.2%, 15-mL bottles (NDC 70069-233-01) from lots BRM13W9001, BRM13W9002, and BRM13W9003 (Exp. 12/20); and BRM13W9004 (Exp. 4/21).
Somerset Therapeutics voluntarily initiated the recall June 4, 2020. On July 7, 2020, the FDA designated it Class III, suggesting use of the affected product is not likely to cause harm.
Brimonidine tartrate is a prescription medication used to lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension.