D-0577-2023 Class II Ongoing
FDA drug recall D-0577-2023 was initiated by RemedyRepack Inc. on May 1, 2023 and is designated Class II. Reason for recall: 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 represente… The recall status is ongoing. Affected quantity: 12 5mL bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2023
- Initiation Date
- May 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 5mL bottles
Product Description
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 for Recall
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.
Distribution Pattern
Product was distrituded to three direct account in PA.
Code Information
Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024