FDA issues urgent recall of 11,000 bottles of medication over serious contamination risk
At this point, it isn't unusual for food products to be recalled over health risks, but when medication is pulled off shelves for the same reason, that is a cause for concern. Contaminated medication can lead to serious health concerns for consumers depending on their medical history. That is exactly what prompted the FDA to recall several thousand bottles of contaminated blood pressure medication.
As per a report by FOX, it was discovered last week that the blood pressure medication in question was contaminated with another drug used to treat cholesterol. The warning was issued on December 1 for more than 11,000 bottles combination medication bisoprolol fumarate and hydrochlorothiazide, which were sold under the brand name Ziac. The relieving bit is that the warning level slapped on by the FDA was a Class III. This meant that it would "not likely to cause adverse health consequences."
The blood pressure medication was tested, and it revealed trace amounts of ezetimibe, which is a prescription drug used to treat high cholesterol. The manufacturer of both the cholesterol drug and the blood pressure medication was Glenmark Pharmaceuticals, based in Elmwood Park, New Jersey. Federal regulators state that the affected pills came in 2.5-milligram and 6.25-milligram doses. Those who have purchased the product might want to take note.
The FDA recall applies to 30-count bottles (NDC 68462-878-30), 100-count bottles (NDC 68462-878-01), and 500-count bottles (NDC 68462-878-05). They also carry expiry dates ranging from November 2025 to May 2026. Neither the FDA nor the manufacturer have responded to FOX’s request for a comment yet. While it has a Class III warning, those who have purchased it would do well to be careful and get the pills checked out as soon as possible.
This is not the first time that blood pressure medication has been recalled. In fact, the most recent one apart from this was only about two months ago. Back then, the FDA had recalled a whopping 580,000 bottles of “prazosin hydrochloride capsules,” which are distributed by Teva Pharmaceuticals USA. The contamination in this case was a lot more serious than a drug that is used to lower cholesterol.
Testing revealed that it contained trace levels of a potentially cancer-causing chemical. In October, the FDA slapped a Class-II warning on the drug, meaning that consumption could lead to “temporary or medically reversible health issues.” The recalled product contained nitrosamine impurities - identified as “N-nitroso Prazosin impurity C”.
According to the federal agency, the recalled products were 181,659 bottles of 1 mg capsules, 291,512 bottles of 2 mg capsules, and 107,673 bottles of 5 mg capsules. Each bottle can contain between 100 and 1,000 capsules, according to the packaging.
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