Cystaran recall: Subpotent
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc.…
Why was Cystaran recalled?
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
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 #: 370655, Exp. 10/31/2020
- Product
- Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc.…
- Recalling firm
- Leadiant Biosciences, Inc.
- Quantity
- 1380 bottles
- Distribution
- PA and Italy
- Recall date
- October 21, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)