Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 4321
Summary
The FDA issued a Class II for Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Sla by Slate Run Pharmaceuticals. Reason: CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits..
Details
Source
Drug Recall
External ID
D-0278-2025
Action Date
2025-03-26
Status
Completed
Category
drug
Product Description
Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
Lot/Code Info: Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026
Quantity Affected: 56,790 bottles
Reason for Recall
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Distribution
Product was distributed to 8 distributors who may have further distribute the product nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-07
Company
Columbus, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Slate Run Pharmaceuticals has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Slate Run Pharmaceuticals) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Slate Run Pharmaceuticals have FDA actions?
Slate Run Pharmaceuticals has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0278-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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