FDA recall D-0683-2018

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

Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany

Key facts

Status

Terminated

Initiation date

2018-04-09

Report date

2018-04-25

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-0683-2018