Brinzolamide Ophthalmic Suspension — Class II drug recall D-0373-2022
Terminated recall by Teva Pharmaceuticals USA, reported 2022-01-26, distributed nationwide. Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block t
| Recall number | D-0373-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2021-12-08 |
| Classified | 2022-01-14 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2023-06-01 |
| Distributed | Nationwide (US) |
| Reason classes | packaging, device malfunction |
| NDC | 00591-2127-12, 00591-2127-79 |
| Lot numbers | BCB10AC2, BCB11AC2, BCB12AC2, BCB1AC2, BCB1DC2, BCB2AC2, BCB2DC2, BCB3AC2, BCB4AC2, BCB4LB2, BCB5AC2, BCB5LB2, BCB6AC2 |
| Expiration dates | 2022-11, 2022-12, 2023-03 |
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, 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0373-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.