October 23, 2020
Leadiant Biosciences Inc. is recalling 1380 bottles of Cystaran (cysteamine ophthalmic solution) 0.44% due to subpotency. According to the October 21, 2020, US Food and Drug Administration (FDA) Enforcement Report, product testing revealed a decreased level of the active ingredient cysteamine hydrochloride.
The recall affects 15-mL bottles of Cystaran ophthalmic solution (NDC 54482-020-01) from lot 370655 (Exp. 10/31/20). The product was manufactured by Hi-Tech Pharmacal Co. Inc. and distributed by Leadiant Biosciences in Pennsylvania, and also in Italy.
Leadiant Biosciences voluntarily initiated the recall September 24, 2020. On October 15, 2020, the FDA designated the recall Class III. Under the recall classification, use of the product is not likely to cause harm.
Cystaran is a prescription eye solution used to treat corneal crystals in patients with cystinosis.