Class III
Terminated
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
- Company
- Leadiant Biosciences, Inc
- Recall Initiated
- February 14, 2018
- Posted
- March 7, 2018
- Recall Number
- D-0550-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,705 bottles
- Firm Location
- Gaithersburg, MD, United States
Reason for Recall
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Distribution
Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy
Lot / Code Info
Lot #: 356075, Exp 2/28/18
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