Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed stability specifications: Out of specification for hardness test
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
Reason Presence of foreign substance: small metallic particles in chewable tablets.
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