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Recall

Cipla USA, Inc.: Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Recall

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Product details: Cinacalcet Hydrochloride Tablets, 90 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 69097-412-02

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Agency
FDA
Record ID
D-0676-2026
Canonical
https://claimwatch-mvp.vercel.app/item/cipla-usa-inc-cinacalcet-hydrochloride-tablets-90-mg-30-count-bottle-rx-only/

What happened?

cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Product details: Cinacalcet Hydrochloride Tablets, 90 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 69097-412-02

Who may be affected?

USA Nationwide

What should consumers do?

Affected quantity: N/A

Official source

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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