Eye Drops Recalled

Teva Pharmaceuticals is recalling nearly 90,000 bottles of ophthalmic brinzolamide because of defective containers. According to the January 26, 2022, US Food and Drug Administration (FDA) Enforcement Report, “the notch in the cap that fits into the nozzle of the dropper could break off and block the dropper, possibly resulting in the product not dispensing.”

The recall affects the following products, which were manufactured by Indoco Remedies Ltd,  Goa, India, for Teva Pharmaceuticals, Parsippany, NJ, and distributed throughout the United States:

• brinzolamide ophthalmic suspension 1%, packaged in 10-ml dropper bottles (NDC 0591-2127-79), from lots BCB1LB2, BCB2LB2, and BCB7LB2 (Exp. 11/22), and BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, and BCB10AC2 (Exp. 12/22); and
• brinzolamide ophthalmic suspension 1%, packaged in 15-ml dropper bottles (NDC 0591-2127-12), from lots BCB4LB2 and BCB5LB2 (Exp. 11/22), BCB1AC2 and BCB2AC2 (Exp. 12/22), and BCB1DC2 and BCB2DC2 (Exp. 3/23).

Teva Pharmaceuticals voluntarily initiated the recall December 8, 2021. The FDA designated the recall Class II on January 14, 2022, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Brinzolamide is available with a prescription to treat high pressure inside the eye due to glaucoma, ocular hypertension, or other eye diseases.