Class II
Ongoing
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
- Company
- Avkare
- Recall Initiated
- November 27, 2024
- Posted
- December 11, 2024
- Recall Number
- D-0109-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,396 bottles
- Firm Location
- Pulaski, TN, United States
Reason for Recall
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Distribution
USA Nationwide
Lot / Code Info
Lot # 44550, Exp 12/31/2024
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