28,000 Bottles of Blood Pressure Medication Recalled Nationwide

(The Epoch Times)—More than 28,000 bottles of a type of heart and blood pressure medication were recalled nationwide due to purity problems, according to a notice published this week by the Food and Drug Administration (FDA).

The recall impacts two lots of ramipril, used to treat hypertension and heart failure-related symptoms after a heart attack. Hikma Pharmaceuticals USA Inc. initiated the recall, while the medication was made by Ohio-based West-Ward Columbus Inc. for Florida-based Exelan Pharmaceuticals, Inc.

Hikma Pharmaceuticals recalled the drug on Aug. 24, while the action was later classified by the FDA on Sept. 3. The recall notice was published on the agency’s website this week.

According to the notice, the recall was initiated due to “failed impurities/degradation specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).” The FDA defines an out-of-specification (OOS) result as when a drug impurity is found that falls “outside the specifications or acceptance criteria established in drug applications.”

The FDA notice did not provide any other details about the failed testing.

The recall was labeled as Class II under the FDA’s three-tiered recall system, which the agency says on its website entails a “situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

Ramipril is described by Drugs.com as an angiotensin-converting enzyme inhibitor, or ACE inhibitor, that can be used to treat high blood pressure, improving the survival rate following a heart attack, and reducing the risk of a heart attack or stroke in higher-risk individuals.

List of Products Under Recall

The recall affects two lots of 10-milligram ramipril, which are contained in two different-sized bottles:

• 100-capsule bottles; NDC 76282-673-01 ; 25,970 bottles; lot AC5470A; and an expiration date of July 2027
• 500-Capsule Bottles (NDC 76282-673-05): 2,384 bottles; lot AC5470B; and expiration date of July 2027

Ramipril is the generic version of the Pfizer Inc.-manufactured Altace, but that drug was not included in this recall.

Other Heart Medications Recalled

In the past several weeks, other heart medications or drugs used to treat high blood pressure were recalled for various reasons in separate incidents.

In an FDA notice published the week of Aug. 5, roughly 5,000 packages of dabigatran etexilate capsules, used to reduce the risk of stroke or blood clotting in people with certain types of atrial fibrillation, were recalled due to elevated impurities. The medication was manufactured by India-based Alkem Laboratories Ltd. and distributed for Indianapolis-based Major Pharmaceuticals.

Another Alkem Laboratories-made drug, olmesartan medoxomil tablets in 10 mg and 20 mg doses, was recalled in late July due to “failed dissolution specifications,” according to the FDA. Olmesartan medoxomil is used to widen the arteries and is used to treat high blood pressure.

In late August, Novartis Pharmaceuticals Corporation recalled one lot of Diovan, the company’s valsartan brand used to treat heart failure and high blood pressure, over potency issues. The lot under recall included 160-milligram tablets in 90-count bottles, with the lot number AV5913C and an expiration date of June 2027.