Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech P...
FDA Recall #D-0550-2018 — Class III — February 14, 2018
Product Description
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.
Recalling Firm
LEADIANT BIOSCIENCES, INC — Gaithersburg, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1,705 bottles
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
Code Information
Lot #: 356075, Exp 2/28/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated