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

FDA recall notice · announced April 25, 2018 · 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%, 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.

Notes

Distribution: Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
Lot/code information: lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
Quantity: 3,398 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0683-2018)

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