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
- April 9, 2018
- Posted
- April 25, 2018
- Recall Number
- D-0683-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,398 bottles
- Firm Location
- Gaithersburg, MD, United States
Reason for Recall
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Distribution
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Lot / Code Info
lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
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