Leadiant Biosciences, Inc. has recalled 1,380 bottles of Cystaran (cysteamine ophthalmic solution) 0.44% eye drops. Testing revealed that the medication is subpotent, meaning it contains a decreased level of the active ingredient, Cysteamine HCl, which may make the treatment less effective. This recall affects 15 mL sterile bottles sold under NDC 54482-020-01 that were distributed in Pennsylvania and Italy. Consumers who are using this medication should contact their healthcare provider or pharmacist for guidance and to obtain a replacement.
The decreased level of the active ingredient means the medication may not provide the full therapeutic benefit intended for the patient's condition. While this specific issue is considered low risk, using subpotent medication can lead to inadequate treatment of the underlying eye condition.
Contact healthcare provider or pharmacist and return product to pharmacy.
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Sources: FDA iRES · Raw API Response
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