FDA Drugs recall ·
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only… recall
- Recall number
- D-0108-2025
- Date
- (initiated November 27, 2024)
- Company / brand
- AvKARE
615 N 1st St, Pulaski, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50,304 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Why was it recalled?
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: 44378, 44597, 45804, Exp 12/31/2024
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0108-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.