Drug recall D-0550-2018
Product
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.
Lots and codes
Lot #: 356075, Exp 2/28/18
Recall details
- Recalling firm
- LEADIANT BIOSCIENCES, INC, Gaithersburg, MD
- Quantity
- 1,705 bottles
- 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
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 14, 2018
- Terminated
- November 29, 2018
Related products
- Cystaran – drug information
- NDC 54482-020 Cystaran · Cysteamine Hydrochloride 6.5 mg/mL · Leadiant Biosciences, Inc.
- NDC 54482-035 Cystaran · Cysteamine Hydrochloride 6.5 mg/mL · Leadiant Biosciences, Inc.