FDA-Drug2025-12-17Class IIPROCESSING DEFECT
Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack carton, Rx Only, Manufactured by: Invagen Pharmaceuticals, Inc., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
OTHERNationwide distribution
Hazard
Failed stability specifications: Out of specification for hardness test
Sold states
Nationwide in the USA
Affected count
N/A
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., (a subsidary of Cipla Ltd) Hauppauge, NY 11786, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33422, Carton NDC 76282-478-90; Bottle NDC 76282-478-13.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2026More Cipla USA, Inc. recalls
- FDA-Drug2026-04-22Cipla Cinacalcet Hydrochloride 30 mg tablets recalled for elevated N-Nitroso impurity
- FDA-Drug2026-04-22Cipla cinacalcet 90 mg tablets recalled for elevated impurity levels
- FDA-Drug2026-04-22Cipla USA Cinacalcet Hydrochloride 60 mg tablets recalled for elevated nitrosamine impurity
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility assurance defect
- FDA-Drug2026-04-15Cipla Lanreotide Injection 120 mg recalled for sterility concerns
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