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.

FDA recall notice · announced October 5, 2022 · Novartis Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot # APCD162, Exp. 01/2023
Quantity: 132,999 cartons
Status: Terminated
Products in this recall event:
- 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 # 007 (D-1543-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.