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AvKARE — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only
Do not stop taking this without speaking to your pharmacist or doctor.
What’s wrong
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.
What to do
Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.
Who to contact: Recalling firm: AvKARE
The product
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Details
- Units affected
- 2,796 bottles
- Recall date
- November 27, 2024
- Brand
- AvKARE
USA Nationwide
The official notice
This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “AvKARE — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Prescription medicine