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-0683-2018
Product summary
- Event
- Event 79849
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,398 bottles
- Official record key
drug-enforcement:D-0683-2018
Official wording
Reason: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Code information: lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
Distribution pattern: Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Derived failure modes
-
Potency or specification failure
Subpotent