Drug recall D-0683-2018
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 numbers: 35866, Exp 6/18; 358663, Exp 7/18
Recall details
- Recalling firm
- LEADIANT BIOSCIENCES, INC, Gaithersburg, MD
- Quantity
- 3,398 bottles
- Distribution
- Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 9, 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.