AvKARE recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Recalled December 11, 2024 · FDA recall D-0108-2025 · AvKARE
Hazard
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. · FDA Class II
Units
50,304 bottles
Sold at
USA Nationwide
Description
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Manufacturer(s)
AvKARE
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →