Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- December 8, 2021
- Posted
- January 26, 2022
- Recall Number
- D-0373-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
- Firm Location
- Parsippany, NJ, United States
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.
Distribution
Nationwide in the USA
Lot / Code Info
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
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