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LEADIANT BIOSCIENCES

2 recalls •

• Categories: Prescription Drugs

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

Class I - Dangerous

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Feb 3, 2023 Prescription Drugs Nationwide View Details →

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

Class I - Dangerous

Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

Sep 24, 2020 Prescription Drugs View Details →

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

Class I - Dangerous

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

Apr 9, 2018 Prescription Drugs View Details →

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

Class I - Dangerous

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

Feb 14, 2018 Prescription Drugs View Details →