February 2018 FDA Recall Cystaran by Leadiant Biosciences, Inc
D-0550-2018 - Subpotent Drug

This Class III drug recall was voluntarily initiated by Leadiant Biosciences, Inc on February 14, 2018 for the product Cystaran. The FDA reported the reason for recall as subpotent drug. The product was distributed in Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy and the recall is currently terminated.

Recall Number: D-0550-2018

Reason for Recall
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Initiated
02-14-2018
Reported
03-07-2018
Quantity
1,705 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79240
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
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.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-29-2018
Product Description About Product Description
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# : 356075, Exp 2/28/18

Affected Packages Involved in this Recall

54482-020-01 Cystaran
54482-020-02 Cystaran
54482-035-02 Cystaran