D-0373-2022 Class II Terminated
FDA drug recall D-0373-2022 was initiated by Teva Pharmaceuticals USA on December 8, 2021 and is designated Class II. 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. The recall status is terminated (terminated June 1, 2023). Affected quantity: a) 66,099 dropper bottles; b) 21,243 dropper bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 26, 2022
- Initiation Date
- December 8, 2021
- Termination Date
- June 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 66,099 dropper bottles; b) 21,243 dropper bottles
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.
Distribution Pattern
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