Recalls / Class III
Class IIID-0550-2018
Product
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
- 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 #: 356075, Exp 2/28/18
Why it was recalled
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Recalling firm
- Firm
- LEADIANT BIOSCIENCES, INC
- Manufacturer
- Leadiant Biosciences, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9841 Washingtonian Blvd Ste 500, N/A, Gaithersburg, Maryland 20878-7352
Distribution
- Quantity
- 1,705 bottles
- Distribution pattern
- Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy
Timeline
- Recall initiated
- 2018-02-14
- FDA classified
- 2018-02-28
- Posted by FDA
- 2018-03-07
- Terminated
- 2018-11-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0550-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.