FDAFDA · Food and drugs·Recall number D-0034-2021
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
Published October 21, 2020 · Recall initiated: September 24, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYSTARAN
- Manufacturer
- Leadiant Biosciences, Inc.
- Distributor
- PA and Italy
- Lot
- Lot #: 370655, Exp. 10/31/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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