FDA-Drug2024-12-11Class II
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
AvKARE
Hazard
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Sold states
USA Nationwide
Affected count
2,396 bottles
Manufactured in
615 N 1st St, Pulaski, TN, United States
Products
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0109-2025Don't want to check this manually?
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