Why it was recalled
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Product description
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Lot numbers, UPCs & expiration codes
Lot # 44550, Exp 12/31/2024
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0109-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Nov 27, 2024
- FDA report date
- Dec 11, 2024
- Quantity
- 2,396 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AvKARE
Original FDA data
Every field from FDA enforcement report D-0109-2025, exactly as published.
Show all FDA fields
- City
- Pulaski
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 95897
- Address
- 615 N 1st St
- Code information
- Lot # 44550, Exp 12/31/2024
- Postal code
- 38478-2403
- Report date
- Dec 11, 2024
- Product type
- Drugs
- Recall number
- D-0109-2025
- Classification
- Class II
- Recalling firm
- AvKARE
- Product quantity
- 2,396 bottles
- Reason for recall
- CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Nov 27, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 5, 2024