Reported Oct 21, 2020 · Terminated
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured…
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%, For Ophthalmic Use Only, 15 mL bottle, Sterile, 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 #: 370655Exp. 10/31/2020
- Amount recalled
- 1380 bottles
Where it was sold
Why it was recalled
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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