Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, ...
FDA Recall #D-0034-2021 — Class III — September 24, 2020
Product Description
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.
Recalling Firm
Leadiant Biosciences, Inc. — Gaithersburg, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
1380 bottles
Distribution
PA and Italy
Code Information
Lot #: 370655, Exp. 10/31/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated