BromSite — Class II drug recall D-0422-2019
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2019-02-06, distributed nationwide. Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
| Recall number | D-0422-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2019-01-24 |
| Classified | 2019-01-30 |
| Reported by FDA | 2019-02-06 |
| Terminated | 2021-02-22 |
| Distributed | Nationwide (US) |
| Quantity | 69,840 bottles |
| Reason classes | sterility |
| NDC | 49708-0754, 49708-0754-41 |
| Lot numbers | V18E01 |
| Expiration dates | 2020-05 |
Product
BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distributed by : Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 49708-754-41
Reason for recall
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
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-0422-2019. 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.