The FDA recently reported a recall for the anti-anxiety medication alprazolam due to concerns about the “potential of [a] foreign substance.” The drug’s manufacturer, Mylan Pharmaceuticals, issued a recall for one lot of the medication, which is better known by its brand name Xanax.
The product in question was distributed in the U.S. in July and August of 2018. The current recall is troubling in light of previous recalls of several ARB medications (sartan drugs) used to treat hypertension as well as the antacid ranitidine when these were discovered to contain trace amounts of the chemical N-Nitrosodimethylamine (NDMA), a known carcinogen. Mylan has not disclosed the nature nor the identity of the contamination, however, the company’s generic versions of three ARB medications were reported as being affected by NDMA contamination last year.
The lot number being recalled is No. 8082708, consisting of bottles of 500 half-milligram pills with an expiration date of September 2020. The FDA believes the risk of illness from taking tainted alprazolam to be quite low, but says that “…the remote risk of infection to a patient cannot be ruled out.” Thus far, there have been no adverse event reports filed in connection with the tainted lot.
Nonetheless, Mylan is advising patients who may have the recalled product to stop taking it. They recommend that anyone with potentially contaminated alprazolam contact a medical waste disposal facility. The FDA is advising them to “…contact their physician or healthcare provider if they have experienced any problems” and submit reports of any adverse events.