# FDA recall D-1328-2022

> **CIPLA** · Class II · drug recall initiated 2022-08-02.

## Product

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

## Reason for recall

Lack of Assurance of Sterility: Complaints received of defective container closure.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1328-2022
- **Recalling firm:** CIPLA
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-08-02
- **Report date:** 2022-08-17
- **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-1328-2022

## Citation

> AI Analytics. FDA recall D-1328-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-1328-2022. Source: US FDA. Licensed CC0.

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