Cystaran recall: Subpotent
Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant…
Why was Cystaran recalled?
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 356075, Exp 2/28/18
- Product
- Cystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant…
- Recalling firm
- LEADIANT BIOSCIENCES, INC
- 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
- Recall date
- March 7, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)