Sodium Chloride Hypertonicity Ophthalmic Ointment — Class II drug recall D-1411-2014
Terminated recall by Bausch & Lomb, Inc., reported 2014-07-02, distributed nationwide. Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a g
| Recall number | D-1411-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bausch & Lomb, Inc., Tampa, FL, United States |
| Recall initiated | 2014-04-10 |
| Classified | 2014-06-25 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2017-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK |
| Quantity | 35,253 tubes |
| UPC / GTIN / UDI-DI | 00309045315385 |
| NDC | 00904-5315-38 |
| Lot numbers | 02/15, 09/15, 10/15, 159101, 169271, 170481 |
Product
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-5315-38, UPC 3 09045 31538 5.
Reason for recall
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
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-1411-2014. 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.