Drug product
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
D-0109-2025
Product summary
- Firm
- AvKARE
- Event
- Event 95897
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,396 bottles
- Official record key
drug-enforcement:D-0109-2025
Official wording
Reason: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Code information: Lot # 44550, Exp 12/31/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP deviations