D-0109-2025 Class II Ongoing
FDA drug recall D-0109-2025 was initiated by AvKARE on November 27, 2024 and is designated Class II. Reason for recall: CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. The recall status is ongoing. Affected quantity: 2,396 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 11, 2024
- Initiation Date
- November 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,396 bottles
Product Description
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.
Distribution Pattern
USA Nationwide
Code Information
Lot # 44550, Exp 12/31/2024