D-0683-2018 Class III Terminated
FDA drug recall D-0683-2018 was initiated by LEADIANT BIOSCIENCES, INC on April 9, 2018 and is designated Class III. Reason for recall: Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride. The recall status is terminated (terminated November 29, 2018). Affected quantity: 3,398 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 25, 2018
- Initiation Date
- April 9, 2018
- Termination Date
- November 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,398 bottles
Product Description
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
Reason for Recall
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Distribution Pattern
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Code Information
lot numbers: 35866, Exp 6/18; 358663, Exp 7/18