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D-0550-2018 Class III Terminated

Recalled by LEADIANT BIOSCIENCES, INC — Gaithersburg, MD

FDA drug recall D-0550-2018 was initiated by LEADIANT BIOSCIENCES, INC on February 14, 2018 and is designated Class III. Reason for recall: Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride. The recall status is terminated (terminated November 29, 2018). Affected quantity: 1,705 bottles.

Recall Details

Product Type
Drugs
Report Date
March 7, 2018
Initiation Date
February 14, 2018
Termination Date
November 29, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,705 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

Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy

Code Information

Lot #: 356075, Exp 2/28/18

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-0683-2018 Class III — Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufact (April 9, 2018)

FDA data resources