FDA Drug recall D-0550-2018
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 fo…
- FDA Drug
- Class III
- terminated
- Published 2018-03-07
On 2018-03-07 the FDA classified a Class III recall of Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 fo… by Leadiant Biosciences, citing subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0550-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-02-14 |
| Published | 2018-03-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leadiant Biosciences |
| Distribution | PA |
Product
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
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Identifiers
| ndc | 54482-020-01 |
|---|---|
| ndc | 54482-020-02 |
| ndc | 54482-035-02 |
| code_info | Lot #: 356075, Exp 2/28/18 |
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-0550-2018%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.