April 2018 FDA Recall Cystaran by Leadiant Biosciences, Inc
D-0683-2018 - Subpotent drug
This Class III drug recall was voluntarily initiated by Leadiant Biosciences, Inc on April 9, 2018 for the product Cystaran. The FDA reported the reason for recall as subpotent drug. The product was distributed in Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany and the recall is currently terminated.
Recall Number: D-0683-2018
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
04-09-2018
04-25-2018
3,398 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.
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
11-29-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
