FDAFDA · Food and drugs·Recall number D-0683-2018
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
Published April 25, 2018 · Recall initiated: April 9, 2018
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: Out of specification for an active ingredient cysteamine hydrochloride.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CYSTARAN
- Manufacturer
- LEADIANT BIOSCIENCES, INC
- Distributor
- Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
- Lot
- lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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