Because of possible contamination, more than 600,000 bottles of the blood pressure drug ramipril have been recalled nationwide. After learning that the medication contains chemicals from an unregulated and uninspected manufacturing plant in India, the FDA announced the recall.
Ramipril: What is it?
More than 2.4 million Americans take the commonly prescribed drug ramipril each year to control high blood pressure by relaxing blood arteries. Although there haven’t been any recorded negative effects, the FDA warns that there may be a chance of contamination even though there isn’t a significant risk to public health generally.
Specifics of the Recall
Bottles of ramipril made by the Indian business Lupin Pharmaceuticals are the subject of the recall. There are three strengths of the impacted capsules available:
2.5 mg, 5 mg, and 10 mg
The bottles have an expiration date of July 2026 and contain 90, 100, or 500 capsules. On November 19, the 2.5 mg dose was added, but the recall initially focused on the 5 mg and 10 mg strengths.
FDA Results
The FDA disclosed that the capsules’ active pharmaceutical ingredient (API) came from a Goa, India-based producer that had not received the required approval or inspection. This resulted to a Class II recall, which recognizes the possibility of negative consequences but suggests a low likelihood of serious harm or death.
How Can Customers Help?
Return or dispose of the product: Customers are encouraged to return the impacted bottles to the retailer for a complete refund or to throw them away.
Speak with a physician: For advice on changing drugs or getting new prescriptions, patients on ramipril should get in touch with their doctor.
FDA source: The FDA website has a comprehensive list of impacted bottles.
More General Issues with Indian-Made Substances
This event is the most recent in a string of recalls involving drugs made in India:
Recall of Cinacalcet: A few weeks earlier, Dr. Reddy’s Laboratories had recalled more than 330,000 bottles of cinacalcet tablets, which are used to treat hyperparathyroidism, because they contained contaminants that can cause cancer.
Contaminated Eye Drops: In 2022, a multi-state health disaster was brought on by eye drops manufactured in India and marketed under names like EzriCare Artificial Tears. Insufficient microbial testing and inappropriate preservatives at the Global Pharma Healthcare plant resulted in bacterial contamination, which caused over 80 infections, vision loss, and four sepsis fatalities.
In conclusion
Despite being classified as low-risk, the latest ramipril recall highlights persistent worries regarding the safety and quality management of medications produced in certain foreign facilities. To be sure their prescription is safe, ramipril users should stay alert, speak with their doctors right once, and review the FDA’s list of recalled goods.