FDA DrugClass II

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.

Failed stability specifications: Out of specification for hardness test…

From the FDA notice · Read the official notice ↗ · All Cipla recalls

What to do

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Is yours affected?

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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.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
1180 boxes
Illnesses reported
None reported
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Classification
Class II
Recall number
D-0217-2026

In the FDA's words

Description
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. Failed stability specifications: Out of specification for hardness test lot# NB240315, exp 12/31/2025 Distribution: Nationwide in the USA Affected quantity: 1180 boxes
Hazard
Failed stability specifications: Out of specification for hardness test

2 products in this recall

The agency lists each product separately. Check every one you might have.

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