The Food and Drug Administration indicated last week it is monitoring a recall of a blood pressure medication that impacts 60,000 tablets distributed around the United States
In a notice published on the FDA website on Feb. 11, 60,000 doxazosin tablets are under recall because the tablets/capsules were imprinted with the “wrong ID.” It’s not clear how the tablets were incorrectly marked.
The distributor, New Jersey-based Unichem Pharmaceuticals Inc., initiated the recall on Jan. 21, but it wasn’t reported by the FDA until Feb. 11. The drug was manufactured at a Unichem Laboratories Limited facility based in Goa, India, according to the notice.
The FDA classified the recall as Class III, or what the agency says is “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
The doxazosin tablets are 4 milligrams per dose in 1,000-count bottles, said the FDA. It was identified as Lot #GDSH25006 with an expiration date of August 2027 and NDC 29300-353-10.
The Mayo Clinic says doxazosin, an alpha-1 adrenergic blocker, can be used to treat high blood pressure as well as other conditions, including the non-cancerous enlargement of the prostate.
According to drug database website ClinCalc, more than 2.7 million doxazosin prescriptions were estimated to have been filled in 2023, making it the 180th most-prescribed medication that year. Around 765,000 people are estimated to have taken the drug that year.
Unichem Laboratories Limited was subject to an FDA import alert in 2018 following an inspection due to what the FDA said were multiple violations at the time. After an FDA inspection, officials wrote in a letter to the company that, in part, “laboratory controls were not followed and documented at the time of performance.”
In separate warnings earlier this month, the FDA confirmed that more than 30,000 prescribed cholesterol drugs were recalled across the United States due to potency and dissolution issues.
According to the agency, New Jersey-based Zydus Pharmaceuticals recalled 22,896 bottles of icosapent ethyl capsules in 120-count bottles in 1-gram doses. A recall issued by drug company AvKare involved 7,991 50-tablet cartons of 10-milligram rosuvastatin is under recall, the FDA said in another notice.
Both recalls were classified as Class II, which is defined by the FDA as a situation where a product or drug “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
It also comes as the FDA in January warned of contamination concerns in a number of over-the-counter drugs, including Advil and Tylenol, that were housed at a Minnesota distribution center due to unsanitary conditions that included the presence of rodents.