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 for recall: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Recall initiated: 20180409
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated