More than 600,000 bottles of the blood pressure medication ramipril have been recalled across the United States due to concerns over potential contamination. The FDA issued the recall after discovering that the drug contained ingredients from an uninspected and unapproved manufacturing facility in India.
What is Ramipril?
Ramipril is a widely prescribed medication, used by more than 2.4 million Americans annually, to manage high blood pressure by relaxing blood vessels. While no adverse events have been reported so far, the FDA cautions that the capsules could pose a contamination risk, though the overall threat to public health is considered low.
Details of the Recall
The recall involves bottles of ramipril produced by Lupin Pharmaceuticals, an Indian company. The affected capsules are available in three strengths:
- 2.5 mg
- 5 mg
- 10 mg
The bottles contain 90, 100, or 500 capsules and have expiration dates extending to July 2026. Initially, the recall targeted the 5mg and 10mg strengths, but on November 19, the 2.5mg dose was added.
FDA Findings
The FDA revealed that the active pharmaceutical ingredient (API) in the capsules was sourced from a manufacturer in Goa, India, which had not undergone proper inspection or approval. This triggered a Class II recall, which indicates a low probability of severe injury or death but acknowledges the potential for adverse effects.
What Should Consumers Do?
- Dispose of or return the product: Customers are advised to either discard the affected bottles or return them to the retailer for a full refund.
- Consult a doctor: Patients taking ramipril should reach out to their healthcare provider for guidance on switching medications or obtaining new prescriptions.
- FDA resource: A complete list of affected bottles is available on the FDA website.
Broader Concerns with Indian-Made Drugs
This incident is the latest in a series of recalls tied to medications manufactured in India:
- Cinacalcet Recall: Just weeks prior, Dr. Reddy’s Laboratories recalled over 330,000 bottles of cinacalcet tablets, used to treat hyperparathyroidism, due to the presence of cancer-causing impurities.
- Contaminated Eye Drops: In 2022, eye drops made in India and sold under brands like EzriCare Artificial Tears caused a multi-state health crisis. Over 80 infections, vision loss, and four deaths from sepsis were linked to bacterial contamination due to inadequate microbial testing and improper preservatives at the Global Pharma Healthcare facility.
Conclusion
While the current recall of ramipril is categorized as low-risk, it underscores ongoing concerns about the safety and quality control of pharmaceuticals manufactured in some overseas facilities. Patients taking ramipril should remain vigilant, consult their doctors promptly, and check the FDA’s list of recalled products to ensure their medication is safe.