Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of Particulate matter: Particulate matter identified as glass.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Stability Data Does Not Support Expiry Date.
Reason Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
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