# FDA recall D-1498-2022

> **CIPLA** · Class II · drug recall initiated 2022-08-22.

## Product

Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton, FL 33432, NDC 76282-708-50.

## Reason for recall

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1498-2022
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-22
- **Report date:** 2022-09-14
- **Termination date:** 2023-11-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warren, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2022

## Citation

> AI Analytics. FDA recall D-1498-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1498-2022. Source: US FDA. Licensed CC0.

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