The Recall Registry
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Home Prescription medicine AvKARE — Cinacalcet Tablets, 90 mg, 30-count…

Food & drug recall · FDANovember 27, 2024Serious

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 seriousFDA 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
Model, lot or SKU numbers
Lot #: 44405, Exp 12/31/2024
Where it was distributed

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

Read it on FDA

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

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