Recommended
The Federal Commission for Protection against Sanitary Risk (Cofepris) issued a sanitary alert on October 5th regarding the counterfeiting of two medications: DARZALEX™ (daratumumab) 400 mg/20 mL and Simponi® (golimumab) 50 mg/0.5 mL, both of which are injectable solutions.
The alert originated from a technical-documentary analysis of information provided by Janssen-Cilag, S.A. de C.V., the importer and distributor of the products. The company reported that the specified lot numbers show irregularities.
Which medications are counterfeit?
Cofepris identified the following products and lots:
| Medicamento | Presentación | Lote | Caducidad | Anomalía |
|---|---|---|---|---|
| DARZALEX™ (daratumumab) | 400 mg, vial | GGH2227 | 06/2028 | Lote inexistente |
| Simponi® (golimumab) | 50 mg/0.5 mL, jeringa prellenada | 01H201KE | MAY/28 | Lote inexistente |
Why does Cofepris consider them counterfeit?
Janssen-Cilag indicated that it has no records of the manufacture, packaging, or release of the mentioned lots. Therefore, it was determined that these are counterfeit products.
Cofepris warns that their identity, purity, efficacy, and quality cannot be guaranteed, meaning their use poses a health risk.
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What does Cofepris recommend?
The health authority asks the public not to purchase or use DARZALEX with lot GGH2227 or Simponi with lot 01H201KE.
In case their potential sale is detected, it is recommended to file a sanitary complaint. If a person experiences an adverse reaction, they can report it through VigiRam or to the Cofepris pharmacovigilance email address.
Recommendations for pharmacies and distributors
Cofepris recommends acquiring medications only through distributors authorized by the holders of the sanitary registrations and keeping documentation that proves legal acquisition, including invoices.
If the specified products are found in stock, they must be immobilized and a corresponding sanitary complaint must be filed. If there are doubts about the authenticity of the products or documents, Cofepris recommends contacting the sanitary registration holder for confirmation.
[Publicidad]