FDA-Drug2025-12-17Class IIPROCESSING DEFECT

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.

OTHERNationwide distributionDrugs
Hazard

Failed stability specifications: Out of specification for hardness test

Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
1180 boxes
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0217-2026

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