Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Reported: December 11, 2024 Initiated: November 27, 2024 #D-0110-2025
Product Description
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Reason for Recall
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Details
- Recalling Firm
- AvKARE
- Units Affected
- 2,796 bottles
- Distribution
- USA Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30. Recalled by AvKARE. Units affected: 2,796 bottles.
Why was this product recalled? ▼
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 11, 2024. Severity: Moderate. Recall number: D-0110-2025.
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