Gaithersburg, MD, United States
LEADIANT BIOSCIENCES, INC recalls
4 recalls recorded since 2018, most recently on 3 February 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 3 February 2023
- Terminated
- 30 September 2024
- Reason
- Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0327-2023
- 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
Terminated Class III Drugs
- Recall started
- 24 September 2020
- Terminated
- 10 November 2021
- Reason
- Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
- Distribution
- PA and Italy
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0034-2021
- 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
Terminated Class III Drugs
- Recall started
- 9 April 2018
- Terminated
- 29 November 2018
- Reason
- Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
- Distribution
- Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0683-2018
- 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
Terminated Class III Drugs
- Recall started
- 14 February 2018
- Terminated
- 29 November 2018
- Reason
- Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0550-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.