# FDA recall D-0577-2023

> **RemedyRepack Inc.** · Class II · drug recall initiated 2023-05-01.

## 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 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

Product was distrituded to three direct account in PA.

## Key facts

- **Recall number:** D-0577-2023
- **Recalling firm:** RemedyRepack Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-05-01
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Indiana, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0577-2023

## Citation

> AI Analytics. FDA recall D-0577-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0577-2023. Source: US FDA. Licensed CC0.

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