FDA Drug recall D-0577-2023
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., India…
- FDA Drug
- Class II
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class II recall of Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., India… by Remedyrepack, citing CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are pu….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0577-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-01 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | PA |
Product
Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1142-00; Source NDC # 17477-0717-10;
Reason
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Identifiers
| code_info | Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0577-2023%22
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