Indian drugmaker Lupin is recalling more than 600,000 bottles of the high blood pressure and heart failure drug ramipril due to the presence of an active pharmaceutical ingredient (API) that came from an unapproved vendor.
The voluntary recall was issued on October 23, according to three separate notifications (PDF 1, PDF 2, PDF 3) posted to the FDA’s website. In total, 616,506 bottles of ramipril are being recalled. The product was distributed nationwide in the U.S. by 30 wholesalers or distributors, according to the notices.
Ramipril is used to treat high blood pressure (hypertension) and heart failure, and it's often prescribed after heart attacks.
The recall is classified as a Class II effort, which is issued when a product has a low chance of causing serious injuries or death.
The recalled products were manufactured by Lupin at its facility in Goa, India.
News of the Lupin recall comes just weeks after the U.S. unit of Indian drugmaker Dr. Reddy’s Laboratories recalled 331,590 bottles of cinacalcet tablets used to treat hyperparathyroidism due to the presence of a known carcinogen. Dr. Reddy’s also issued three separate recalls for drugs that were distributed nationwide.
Lupin’s latest recall falls almost two years to the date after it suspended production of drugs bound for the U.S. from a troubled Tarapur, Maharashtra, active pharmaceutical ingredient plant in India.
That action was taken after the company received a warning letter from the FDA in the wake of an inspection that found the facility failed to establish proper cleaning protocols. The company also failed to set up in-process samples and controls, and its own investigations into the plant’s deficiencies were lacking, the FDA found.