Recalls / Class II

Class IID-0109-2025

Product

Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

Affected lot / code info

Lot # 44550, Exp 12/31/2024

Why it was recalled

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Recalling firm

Firm

AvKARE

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

615 N 1st St, Pulaski, Tennessee 38478-2403

Distribution

Quantity

2,396 bottles

Distribution pattern

USA Nationwide

Timeline

Recall initiated

2024-11-27

FDA classified

2024-12-05

Posted by FDA

2024-12-11

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0109-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.