Drug 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
D-0550-2018
Product summary
- Event
- Event 79240
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1,705 bottles
- Official record key
drug-enforcement:D-0550-2018
Official wording
Reason: Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Code information: Lot #: 356075, Exp 2/28/18
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
Derived failure modes
-
Potency or specification failure
Subpotent