# FDA recall D-0034-2021

> **Leadiant Biosciences, Inc.** · Class III · drug recall initiated 2020-09-24.

## Product

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only,  Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

## Reason for recall

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

## Distribution

PA and Italy

## Key facts

- **Recall number:** D-0034-2021
- **Recalling firm:** Leadiant Biosciences, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-09-24
- **Report date:** 2020-10-21
- **Termination date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gaithersburg, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2021

## Citation

> AI Analytics. FDA recall D-0034-2021. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/D-0034-2021. Source: US FDA. Licensed CC0.

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