Slate Run Pharmaceuticals 2025-03-26 Health serious FDA
Health · FDA · Recall #FDA-D-0279-2025
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run… Recall
Issued March 26, 2025 · Slate Run Pharmaceuticals
In March 2025, Slate Run Pharmaceuticals recalled the Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
What you should do
- 1 Stop using Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Slate Run Pharmaceuticals 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
- Slate Run Pharmaceuticals
- Category
- Health
- Recall date
- March 26, 2025
- Units affected
- Not reported
- Sold at
- Product was distributed to 8 distributors who may have further distribute the product nationwide.
- Recall number
- FDA-D-0279-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Slate Run Pharmaceuticals has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.