Why it was recalled
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Product description
Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
Lot numbers, UPCs & expiration codes
Lot # APCD162, Exp. 01/2023
Where it was sold
Nationwide and Puerto Rico
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-1543-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 16, 2022
- FDA report date
- Oct 5, 2022
- Quantity
- 132,999 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novartis Pharmaceuticals Corporation
Original FDA data
Every field from FDA enforcement report D-1543-2022, exactly as published.
Show all FDA fields
- City
- East Hanover
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90862
- Address
- 1 Health Plz
- Code information
- Lot # APCD162, Exp. 01/2023
- Postal code
- 07936-1016
- Report date
- Oct 5, 2022
- Product type
- Drugs
- Recall number
- D-1543-2022
- Classification
- Class II
- Recalling firm
- Novartis Pharmaceuticals Corporation
- Product quantity
- 132,999 cartons
- Termination date
- Mar 11, 2024
- Reason for recall
- CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 26, 2022