FDAFDA · Food and drugs·Recall number D-0109-2025
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Published December 11, 2024 · Recall initiated: November 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- AvKARE
- Distributor
- USA Nationwide
- Lot
- Lot # 44550, Exp 12/31/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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