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
Reported: October 21, 2020 Initiated: September 24, 2020 #D-0034-2021
Product 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
Reason for Recall
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Details
- Recalling Firm
- Leadiant Biosciences, Inc.
- Units Affected
- 1380 bottles
- Distribution
- PA and Italy
- Location
- Gaithersburg, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Leadiant Biosciences, Inc.. Units affected: 1380 bottles.
Why was this product recalled? ▼
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 21, 2020. Severity: Low. Recall number: D-0034-2021.
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