Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79...
FDA Recall #D-0373-2022 — Class II — December 8, 2021
Product Description
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, Inc. Parsippany, NJ
Reason for Recall
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.
Recalling Firm
Teva Pharmaceuticals USA — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
a) 66,099 dropper bottles; b) 21,243 dropper bottles
Distribution
Nationwide in the USA
Code Information
Lots: a)BCB1LB2, BCB2LB2, BCB7LB2, Exp. 11/2022; Lots: BCB11AC2, BCB12AC2, BCB3AC2, BCB4AC2, BCB5AC2, BCB6AC2, BCB10AC2, Exp. 12/2022; b) Lots: BCB4LB2, BCB5LB2, Exp. 11/2022; Lots: BCB1AC2, BCB2AC2, Exp. 12/2022; Lots: BCB1DC2, BCB2DC2, Exp. 03/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated