FDA orders recall of antianemia injectable drug
The Food and Drug Administration (FDA) has ordered the recall of a batch of an antianemia injectable drug after its Swiss manufacturer reported it to be inferior.
In an advisory, Health Secretary Janette Garin, also FDA acting director general, identified the product as Epoetin Alfa (Recombinant Human Erythropoietin) 4,000 IU/0.4 mL solution for injection with the brand name Eprex.
Drug stores and pharmacies were advised to take off their shelves the substandard drug with batch number EAS4300 (expiry date June 2015) while hospitals were ordered to stop administering it to patients.
The drug product was manufactured in Switzerland by Cilag AG and imported by Johnson and Johnson (Philippines).
The FDA issued the recall order after it received a “rapid alert notification” about a quality defect from Agence Nationale de Sécurité du Médicament et des Produits de santé (ANSM) in France coursed through the World Health Organization, according to Garin.
The drug product is used for the treatment of anemia of chronic renal failure, anemia associated with HIV infections and anemia of malignancy. It is also given to adult patients with mild to moderate anemia who are scheduled for elective orthopedic surgery with expected moderate blood loss.
Earlier, the manufacturer found out that the batch did not fit “the historical stability profile meant for oxidized methionine and may not meet the specification to end of shelf life,” Garin said.
In a separate advisory, the FDA also warned the public against using four unregistered drug products being sold in the market, among them a decongestant, an herbal-based mouth spray and vitamins.
It identified the products that have not undergone government evaluation and registration as Naphazoline HCl (Pi Yen Chin) 1:1000 per 10 mL solution and Guilin Watermelon Frost Powder, both from China; Ascorbic Acid (GNC Vitamin C with Rose Hips) 1000 mg tablet from Pittsburgh, Pennsylvania; and La Colina Vino de Quino Con Tiki-Tiki 350 mL from the Philippines.
Garin stated that these medications posed potential health risks and injury to consumers since they did not undergo mandatory product evaluation, registration and testing by the government.
She ordered the seizure of the four drug products to protect public health and safety.
