Home / Recalls / LEADIANT BIOSCIENCES, INC / D-0683-2018

D-0683-2018 Class III Terminated

Recalled by LEADIANT BIOSCIENCES, INC — Gaithersburg, MD

Recall Details

Product Type
Drugs
Report Date
April 25, 2018
Initiation Date
April 9, 2018
Termination Date
November 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,398 bottles

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

Reason for Recall

Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.

Distribution Pattern

Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany

Code Information

lot numbers: 35866, Exp 6/18; 358663, Exp 7/18

Other recalls by LEADIANT BIOSCIENCES, INC

  • D-0327-2023 Class II — Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, (February 3, 2023)
  • D-0034-2021 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL (September 24, 2020)
  • D-0550-2018 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufact (February 14, 2018)