FDA Drug recall D-0034-2021
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal…
- FDA Drug
- Class III
- terminated
- Published 2020-10-21
On 2020-10-21 the FDA classified a Class III recall of Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal… by Leadiant Biosciences, citing subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0034-2021 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-09-24 |
| Published | 2020-10-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leadiant Biosciences |
| Distribution | PA |
Product
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
Reason
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Identifiers
| ndc | 54482-020-01 |
|---|---|
| ndc | 54482-020-02 |
| ndc | 54482-035-02 |
| code_info | Lot #: 370655, Exp. 10/31/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0034-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.