September 2020 FDA Recall Cystaran by Leadiant Biosciences, Inc.
D-0034-2021 - Subpotent Drug
This Class III drug recall was voluntarily initiated by Leadiant Biosciences, Inc. on September 24, 2020 for the product Cystaran. The FDA reported the reason for recall as subpotent drug. The product was distributed in PA and Italy and the recall is currently terminated.
Recall Number: D-0034-2021
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
09-24-2020
10-21-2020
1380 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Leadiant Biosciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
PA and Italy
11-10-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 370655, Exp. 10/31/2020
