The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public of the recall of some batches of Regpara tablets 25mg by DKSH Hong Kong Limited as a precautionary measure due to impurities in the product.
The manufacturer reports that the product contains an impurity, N-nitroso-cinacalcet, which exceeds the acceptable daily intake. N-nitroso-cinacalcet is classified as a probable human carcinogen based on results from laboratory tests.
Regpara tablets 25mg contains cinacalcet as active ingredient. It is a prescription medicine primarily used for the treatment of secondary hyperparathyroidism in patients undergoing maintenance dialysis.
Product Details
The details of the affected batches are as follows.
Name of Kyowa Kirin’s Product | Hong Kong Registration Number | Batch Number |
Regpara Tab 25mg | HK-58066 | DES169675 |
Regpara Tab 25mg | HK-58066 | DHS171505 |
Regpara Tab 25mg | HK-58066 | DMS173037 |
Regpara Tab 25mg | HK-58066 | DBS176064 |
Regpara Tab 25mg | HK-58066 | DBS176065 |
Regpara Tab 25mg | HK-58066 | EES176886 |
Regpara Tab 25mg | HK-58066 | EES177675 |
Regpara Tab 25mg | HK-58066 | EHS178805 |
Regpara Tab 25mg | HK-58066 | EHS179575 |
Regpara Tab 25mg | HK-58066 | ENS181132 |
Risk Statement:
The administration of contaminated drugs poses significant risks to human health. As earlier mentioned, N-nitroso-cinacalcet is classified as a probable human carcinogen, which can lead to life-threatening health conditions.
Although the products are not in the NAFDAC database, NAFDAC urges importers, distributors, retailers, healthcare providers, and patients to exercise caution and vigilance throughout the supply chain. This is essential to prevent the importation, distribution, sale, administration, or use of recalled products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the affected product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
NAFDAC……….Customer-focused, Agency-minded!!!
