# FDA recall D-0550-2018

> **LEADIANT BIOSCIENCES, INC** · Class III · drug recall initiated 2018-02-14.

## Product

Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, 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: Out of specification for an active ingredient cysteamine hydrochloride.

## Distribution

Product was distributed to one specialty pharmacy distributor in the US  Walgreens Specialty Pharmacy  16287, 130 Enterprise Drive  Pittsburgh, PA 15275    Foreign Account: Italy

## Key facts

- **Recall number:** D-0550-2018
- **Recalling firm:** LEADIANT BIOSCIENCES, INC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-14
- **Report date:** 2018-03-07
- **Termination date:** 2018-11-29

- **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-0550-2018

## Citation

> AI Analytics. FDA recall D-0550-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0550-2018. Source: US FDA. Licensed CC0.

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