Cipla USA, Inc. — Class II: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla
Cipla USA, Inc. has initiated a Class II recall for Cinacalcet Hydrochloride Tablets (30 mg) due to cGMP deviations involving the presence of N-nitroso-cinacalcet exceeding the acceptable daily intake (ADI) levels.
This recall affects Cipla USA, Inc., its manufacturing facility in Patalganga, India, and stakeholders involved in the distribution and quality oversight of cinacalcet hydrochloride tablets.
The presence of nitrosamine impurities above established ADI limits suggests potential gaps in manufacturing controls or stability testing. This event highlights ongoing regulatory scrutiny regarding mutagenic impurities in generic drug products and may indicate a need for enhanced raw material screening or process validation to mitigate impurity formation.
QA and compliance teams should verify if their own cinacalcet inventories or manufacturing processes are susceptible to nitrosamine formation and ensure testing protocols are aligned with current acceptable daily intake (ADI) limits. Inventory managers should identify and quarantine affected NDC 69097-410-02 lots if applicable.
Class II. Reason: cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).. Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-410-02. Firm: Cipla USA, Inc. (Warren NJ United States). Status: Ongoing.
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