FDA recall D-0550-2018

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

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

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0550-2018