Why it was recalled
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 356075, Exp 2/28/18
Where it was sold
Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: 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-0550-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 14, 2018
- FDA report date
- Mar 7, 2018
- Quantity
- 1,705 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LEADIANT BIOSCIENCES, INC
Original FDA data
Every field from FDA enforcement report D-0550-2018, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 79240
- Address
- 9841 Washingtonian Blvd Ste 500
- Code information
- Lot #: 356075, Exp 2/28/18
- Postal code
- 20878-7352
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0550-2018
- Classification
- Class III
- Recalling firm
- LEADIANT BIOSCIENCES, INC
- Product quantity
- 1,705 bottles
- Termination date
- Nov 29, 2018
- Reason for recall
- Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to one specialty pharmacy distributor in the US Walgreens Specialty Pharmacy 16287, 130 Enterprise Drive Pittsburgh, PA 15275 Foreign Account: Italy
- Recall initiation date
- Feb 14, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2018