Status
Ongoing
Drug Enforcement D-0577-2023
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.
Classification
Class II
Report Date
May 24, 2023
Termination Date
—
Product Information
- 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;
- Product quantity
- 12 5mL bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distrituded to three direct account in PA.
Location & Firm
- Recalling firm
- RemedyRepack Inc.
- Address
-
625 Kolter Dr Ste 4
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0577-2023
- Event ID
- 92239
- Recall initiation date
- May 1, 2023
- Center classification date
- May 16, 2023
- Code info
- Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
- More code info
- —