AvKARE 2024-12-11 Health serious FDA
Health · FDA · Recall #FDA-D-0109-2025
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,… Recall
Issued December 11, 2024 · AvKARE
In December 2024, AvKARE recalled the Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
What you should do
- 1 Stop using Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact AvKARE to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- AvKARE
- Category
- Health
- Recall date
- December 11, 2024
- Units affected
- Not reported
- Sold at
- USA Nationwide
- Recall number
- FDA-D-0109-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- AvKARE has 10 recalls in our database, including 1 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.