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
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #: 370655, Exp. 10/31/2020
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Leadiant Biosciences, Inc.
- Reason for Recall:
- Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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
Product Codes/Lot Numbers:
Lot #: 370655, Exp. 10/31/2020
Distribution:
Distributed in: PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0034-2021
Related Recalls
Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.
Subpotent drug: Out of specification for an active ingredient cysteamine hydrochloride.
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.