D-0034-2021 Class III Terminated
FDA drug recall D-0034-2021 was initiated by Leadiant Biosciences, Inc. on September 24, 2020 and is designated Class III. Reason for recall: Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl. The recall status is terminated (terminated November 10, 2021). Affected quantity: 1380 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 21, 2020
- Initiation Date
- September 24, 2020
- Termination Date
- November 10, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1380 bottles
Product Description
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
Reason for Recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Distribution Pattern
PA and Italy
Code Information
Lot #: 370655, Exp. 10/31/2020