# FDA recall D-1628-2020

> **Akorn, Inc.** · Class II · drug recall initiated 2020-09-03.

## Product

Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01

## Reason for recall

CGMP Deviations

## Distribution

Nationwide in CA, IN, VA, NJ, NY, RI, FL, TX, MO, PA, MI, AL, TN, SC

## Key facts

- **Recall number:** D-1628-2020
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-03
- **Report date:** 2020-10-07
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1628-2020

## Citation

> AI Analytics. FDA recall D-1628-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1628-2020. Source: US FDA. Licensed CC0.

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