Brinzolamide Ophthalmic Suspension recalled for defective container caps

Plain-English summary

Teva Pharmaceuticals USA is recalling Brinzolamide Ophthalmic Suspension, USP 1%, distributed nationwide. The product is supplied in 10 ml and 15 ml dropper bottles (NDC 0591-2127-79 and NDC 0591-2127-12, respectively). The recall affects approximately 66,099 10 ml dropper bottles and 21,243 15 ml dropper bottles.

The reason for the recall is a defective container: 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. This is a Class II recall issued by the FDA.

Affected lot numbers are: for 10 ml bottles—BCB1LB2, BCB2LB2, BCB7LB2 (expiring 11/2022); BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, BCB10AC2 (expiring 12/2022); and for 15 ml bottles—BCB4LB2, BCB5LB2 (expiring 11/2022); BCB1AC2, BCB2AC2 (expiring 12/2022); BCB1DC2, BCB2DC2 (expiring 03/2023).

Consumers who have this product should contact their healthcare provider or pharmacy for guidance. The product was manufactured in India by Indoco Remedies Limited for Teva Pharmaceuticals USA, Inc.

The recalled product

Product

Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA,

Manufacturer

Teva Pharmaceuticals USA

Category

Drug — Ophthalmic

Hazard

• defective-cap
• dispensing-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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