Recalling firm
ACCORD HEALTHCARE, INC.
Product type
Drug
Status
Ongoing
Report date
2024-11-06
Distribution
Nationwide in the USA and PR
Firm state
NC
Product quantity
N/A
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product description
Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Code / lot info
a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.