Product: Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., Hauppauge, NY 11786, Manufactured for : Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-936-98.
Reason for recall: Failed stability specifications: Out of specification for hardness test
Recall initiated: 20251024
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated