Reported Apr 25, 2018 · Terminated
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc.…
Leadiant Biosciences, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEADIANT BIOSCIENCES, INC · 9841 Washingtonian Blvd Ste 500 · Gaithersburg, MD · 20878-7352
Is this the product you have?
- 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
- Lot codes and dates
- lot numbers
35866Exp 6/18358663Exp 7/18
- lot numbers
- Amount recalled
- 3,398 bottles
Where it was sold
Why it was recalled
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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