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Eye Solution Recalled
10/23/2020
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.
—Jolynn Tumolo