Concerns about possible contamination have led to the recall of over 600,000 bottles of the blood pressure drug ramipril nationwide. The FDA recalled the medication after learning that it contains chemicals from an unlicensed and uninspected Indian manufacturing plant.
Ramipril: what is it?
Every year, over 2.4 million Americans use the commonly prescribed drug ramipril, which relaxes blood arteries to lower high blood pressure. The FDA warns that the capsules may provide a risk of contamination, even if no negative incidents have been reported thus far. However, the total risk to public health is deemed to be minimal.
Information on the Recall
The recall concerns ramipril bottles made by the Indian business Lupin Pharmaceuticals. There are three strengths available for the impacted capsules:
2.5, 5, and 10 mg
The pills come in bottles with 90, 100, or 500 doses, and they expire in July 2026. The 2.5 mg dose was added on November 19, while the recall initially focused on the 5 mg and 10 mg levels.
FDA’s conclusions
The active pharmaceutical ingredient (API) in the capsules came from a Goa, India-based firm that had not received the required inspection or approval, the FDA disclosed. A Class II recall, which recognizes the possibility of negative effects but suggests a low likelihood of serious harm or death, was triggered by this.
How Do Customers Need to Act?
Throw away or return the product: Customers are encouraged to either throw away the impacted bottles or send them back to the store for a complete reimbursement.
See a physician: If a patient is taking ramipril and needs help switching medications or getting a new prescription, they should contact their doctor.
FDA website: The FDA website has a full list of the impacted bottles.
Wider Issues with Drugs Made in India
The most recent of several recalls involving drugs made in India is this one:
More than 330,000 bottles of cinacalcet tablets, which are used to treat hyperparathyroidism, were recalled by Dr. Reddy’s Laboratories a few weeks ago because they contained contaminants that can cause cancer.
A multi-state health crisis was brought on by contaminated eye drops in 2022 that were manufactured in India and marketed under names like EzriCare Artificial Tears. The Global Pharma Healthcare facility’s poor preservatives and insufficient microbial testing resulted in bacterial contamination that caused over 80 infections, blindness, and four sepsis deaths.
In conclusion,
Even though the ramipril recall is currently considered low-risk, it highlights persistent worries regarding the safety and quality control of medications produced in certain foreign facilities. To make sure ramipril is safe, patients should not lose their vigilance, seek immediate medical advice, and review the FDA’s list of recalled goods.
