Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: 44378, 44597, 45804, Exp 12/31/2024
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AvKARE
- Reason for Recall:
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Product Codes/Lot Numbers:
Lot#: 44378, 44597, 45804, Exp 12/31/2024
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0108-2025
Related Recalls
Failed Content Uniformity Specifications
Class I - Dangerous
Presence of a foreign substance.
Class I - Dangerous
Presence of a foreign substance.