Drug 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;
D-0577-2023
Product summary
- Event
- Event 92239
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 5mL bottles
- Official record key
drug-enforcement:D-0577-2023
Official wording
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.
Code information: Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
Distribution pattern: Product was distrituded to three direct account in PA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations