Reported Dec 11, 2024 · Ongoing
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
AvKARE
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: AvKARE · 615 N 1st St · Pulaski, TN · 38478-2403
Is this the product you have?
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only
- Manufactured forAvKARE, Pulaski, TN 38478, NDC 42291-461-30
- Lot codes and dates
Lot #: 44405Exp 12/31/2024
- Amount recalled
- 2,796 bottles
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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