Drug Enforcement D-0109-2025

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

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

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Product Information

Product description
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Product quantity
2,396 bottles
Reason for recall
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0109-2025
Event ID
95897
Recall initiation date
November 27, 2024
Center classification date
December 5, 2024
Code info
Lot # 44550, Exp 12/31/2024
More code info
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