FDA Drug recall D-1411-2014
Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterpr…
- FDA Drug
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube per carton, Distributed by Major Pharmaceuticals, 31778 Enterpr… by Bausch And Lomb, citing crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1411-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-10 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bausch And Lomb |
| Distribution | US |
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
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Identifiers
| upc | 309045315385 |
|---|---|
| code_info | Lot #'s: 159101, Exp 02/15; 169271, Exp 09/15; and 170481, Exp 10/15 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1411-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.