FDA Drug recall D-1396-2019
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North…
- FDA Drug
- Class III
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class III recall of Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North… by Bausch And Lomb, citing failed Stability Specifications: Out of specification for viscosity.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1396-2019 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-06-17 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bausch And Lomb |
| Distribution | US |
Product
Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g box, Bausch & Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, NDC 24208-503-07.
Reason
Failed Stability Specifications: Out of specification for viscosity.
Identifiers
| ndc | 24208-503-07 |
|---|---|
| ndc | 24208-503-48 |
| ndc | 24208-503-96 |
| code_info | Lot #s: 282611; 283431; 283441; 283451, Exp. 10/2019; 282971; 282981; 283611; 283621; 283631, Exp. 11/2019. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1396-2019%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.