FDA Drug recall D-0924-2023
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and…
- FDA Drug
- Class III
- terminated
- Published 2023-07-26
On 2023-07-26 the FDA classified a Class III recall of Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and… by Sun Pharmaceutical Industries, citing superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0924-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2023-07-05 |
| Published | 2023-07-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India.
Reason
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Identifiers
| ndc | 62756-232-90 |
|---|---|
| ndc | 62756-232-55 |
| ndc | 62756-232-56 |
| code_info | Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/…Lot#: a) BAC0334A, Exp 06/2023; BAC0532A, Exp 11/2023 BAD0407A, Exp 08/2024 BAD0425A, Exp 08/2024; b) BAC0335A, Exp 06/2023, BAC0533A, Exp 10/2023, BAD0148A, Exp 03/2024, BAD0320A, Exp 07/2024 |
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-0924-2023%22
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