FDA recall D-0034-2021

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

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

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