Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech P...
FDA Recall #D-0683-2018 — Class III — April 9, 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
3,398 bottles
Distribution
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Code Information
lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated