Drug recall D-0109-2025

Class II Ongoing reported Dec 11, 2024

Product

Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

Reason for recall

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Lots and codes

Lot # 44550, Exp 12/31/2024

Recall details

Recalling firm
AvKARE, Pulaski, TN
Quantity
2,396 bottles
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 27, 2024