FDAOctober 10, 2024drug
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
What to do
FDA enforcement status: Ongoing
Brands named
accord healthcareaccord
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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