Drug 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
D-0034-2021
Product summary
- Event
- Event 86525
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1380 bottles
- Official record key
drug-enforcement:D-0034-2021
Official wording
Reason: Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Code information: Lot #: 370655, Exp. 10/31/2020
Distribution pattern: PA and Italy
Derived failure modes
-
Potency or specification failure
Subpotent