Food, drugs, devices › LEADIANT BIOSCIENCES, INC
Drug recall: Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amit
FDA enforcement event 79240 is a drug recall by LEADIANT BIOSCIENCES, INC of Gaithersburg, MD, initiated 14 Feb 2018 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 29 Nov 2018. Initiation: voluntary: firm initiated. LEADIANT BIOSCIENCES, INC has 4 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
LEADIANT BIOSCIENCES, INC, Gaithersburg, MD.
Reason for recall
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 1,705 bottles | Class III | Terminated | 7 Mar 2018 |
Context
Other enforcement events for LEADIANT BIOSCIENCES, INC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Feb 2023 | Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianap | Drug | Class II | 1 |
| 24 Sep 2020 | Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured b | Drug | Class III | 1 |
| 9 Apr 2018 | Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc. Amity | Drug | Class III | 1 |
All 4 events for LEADIANT BIOSCIENCES, INC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 29 Nov 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.