Recalls / Class II
Class IID-0577-2023
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;
- Affected lot / code info
- Lot # B1643789-041022, EXP 03/31/2024; B1894150-100722, B1891573-100622, EXP. 7/31/2024
Why it was recalled
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.
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 12 5mL bottles
- Distribution pattern
- Product was distrituded to three direct account in PA.
Timeline
- Recall initiated
- 2023-05-01
- FDA classified
- 2023-05-16
- Posted by FDA
- 2023-05-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0577-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.