Cystaran Solution
FDA Recall NDC 54482-035
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Cystaran (NDC 54482-035). A significant event, classified as Class III, was initiated on Sep 24, 2020 by Leadiant Biosciences, Inc.. The reported reason for this action was: "Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Sep 24, 2020
Oct 21, 2020
1380 bottles
Recall Profile & Regulatory Data
Event ID
86525
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Leadiant Biosciences, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
PA and Italy
Termination Date
Nov 10, 2021
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
Batch or Lot Expiration Information
Lot# : 370655, Exp. 10/31/2020
Affected Packages Involved in this Recall
54482-020-01Product
54482-020-02Product
54482-035-02Product
Class III Terminated
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Apr 09, 2018
Apr 25, 2018
3,398 bottles
Recall Profile & Regulatory Data
Event ID
79849
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LEADIANT BIOSCIENCES, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Termination Date
Nov 29, 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
Batch or Lot Expiration Information
Lot# lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
Affected Packages Involved in this Recall
54482-020-01Product
54482-020-02Product
54482-035-02Product
Class III Terminated
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Feb 14, 2018
Mar 07, 2018
1,705 bottles
Recall Profile & Regulatory Data
Event ID
79240
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
LEADIANT BIOSCIENCES, INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
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
Nov 29, 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
Batch or Lot Expiration Information
Lot# : 356075, Exp 2/28/18
Affected Packages Involved in this Recall
54482-020-01Product
54482-020-02Product
54482-035-02Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
