Class III
Terminated
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
- Company
- Leadiant Biosciences, Inc
- Recall Initiated
- September 24, 2020
- Posted
- October 21, 2020
- Recall Number
- D-0034-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1380 bottles
- Firm Location
- Gaithersburg, MD, United States
Reason for Recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Distribution
PA and Italy
Lot / Code Info
Lot #: 370655, Exp. 10/31/2020
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