Recall record at a glance
| Official record | D-0279-2025 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Slate Run Pharmaceuticals |
| Report date | Mar 26, 2025 |
| Recall initiation date | Mar 7, 2025 |
| Quantity | 2,444 bottles |
| Location | Columbus, OH, United States |
Official product description
Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04
Why the product was recalled
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Distribution information
Product was distributed to 8 distributors who may have further distribute the product nationwide.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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