Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01

FDA recall notice · announced October 21, 2020 · Leadiant Biosciences

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, 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: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.

Notes

Distribution: PA and Italy
Lot/code information: Lot #: 370655, Exp. 10/31/2020
Quantity: 1380 bottles
Status: Terminated
Products in this recall event:
- Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc. (D-0034-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.