Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic… — Class III drug recall D-0162-2020
Terminated recall by Sandoz Inc, reported 2019-11-06, distributed nationwide. Labeling: Incorrect or missing package insert.
| Recall number | D-0162-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2019-10-17 |
| Classified | 2019-10-28 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2022-01-19 |
| Distributed | Nationwide (US) |
| Quantity | 346,929 bottles |
| Reason classes | labeling |
| NDC | 61314-0630, 61314-0630-06 |
| Lot numbers | 287880F, 287881F, 290555F, 290556F, 290557F, 293386F, 293387F, 293388F, 293389F, 293390F, 293391F, 293392F, 295342F, 295344F, 295345F, 295346F, 295347F, 298823F, 298825F, 304495F, 304496F, 304497F, 304963F, 304964F, 304966F |
| Expiration dates | 2019-10-31, 2019-11-30, 2020-02-29, 2020-03-31, 2020-05-31, 2020-06-30, 2020-07-31, 2020-08-31, 2020-10-31, 2020-11-30, 2020-12-31, 2021-01-31, 2021-03-31, 2021-04-30, 2021-05-31 |
Product
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
Reason for recall
Labeling: Incorrect or missing package insert.
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-0162-2020. 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.