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 numbers: 35866, Exp 6/18; 358663, Exp 7/18
Where it was sold
Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
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-0683-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 9, 2018
- FDA report date
- Apr 25, 2018
- Quantity
- 3,398 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LEADIANT BIOSCIENCES, INC
Original FDA data
Every field from FDA enforcement report D-0683-2018, exactly as published.
Show all FDA fields
- City
- Gaithersburg
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 79849
- Address
- 9841 Washingtonian Blvd Ste 500
- Code information
- lot numbers: 35866, Exp 6/18; 358663, Exp 7/18
- Postal code
- 20878-7352
- Report date
- Apr 25, 2018
- Product type
- Drugs
- Recall number
- D-0683-2018
- Classification
- Class III
- Recalling firm
- LEADIANT BIOSCIENCES, INC
- Product quantity
- 3,398 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
- Walgreens Specialty Pharmacy Pittsburg, PA Italy and Germany
- Recall initiation date
- Apr 9, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2018