Recalls / Class III
Class IIID-0034-2021
Product
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
- Brand name
- Cystaran
- Generic name
- Cysteamine Hydrochloride
- Active ingredient
- Cysteamine Hydrochloride
- Route
- Ophthalmic
- NDCs
- 54482-020, 54482-035
- FDA application
- NDA200740
- Affected lot / code info
- Lot #: 370655, Exp. 10/31/2020
Why it was recalled
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Recalling firm
- Firm
- Leadiant Biosciences, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, Maryland 20878-7352
Distribution
- Quantity
- 1380 bottles
- Distribution pattern
- PA and Italy
Timeline
- Recall initiated
- 2020-09-24
- FDA classified
- 2020-10-15
- Posted by FDA
- 2020-10-21
- Terminated
- 2021-11-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0034-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.