Why it was recalled
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
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
Lot numbers, UPCs & expiration codes
Lot #: 370655, Exp. 10/31/2020
Where it was sold
PA and Italy
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0034-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 24, 2020
- FDA report date
- Oct 21, 2020
- Quantity
- 1380 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Leadiant Biosciences, Inc.
Original FDA data
Every field from FDA enforcement report D-0034-2021, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 86525
- Address
- 9841 Washingtonian Blvd Ste 500
- Code information
- Lot #: 370655, Exp. 10/31/2020
- Postal code
- 20878-7352
- Report date
- Oct 21, 2020
- Product type
- Drugs
- Recall number
- D-0034-2021
- Classification
- Class III
- Recalling firm
- Leadiant Biosciences, Inc.
- Product quantity
- 1380 bottles
- Termination date
- Nov 10, 2021
- Reason for recall
- Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- PA and Italy
- Recall initiation date
- Sep 24, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 15, 2020