Type of Posting: Publication Announcement
Posting Date: 26–Feb–2021
On March 1, 2021, the pop-up text added to USP-NF Online for the substance and drug product monographs listed below in Table 1 will be removed. The pop-ups were added to direct users attention to the initial FDA resources regarding the voluntary recall of several medicines containing Angiotensin II Receptor Blockers (ARBs) as described in the Compendial Notice posted on August 30, 2019.
Current information about FDA’s response to nitrosamine impurities in medications, including in ARBs, can be found at:
https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications.
Table 1. ARB monographs containing pop-up text to be removed.
Drug Substance |
Drug Product |
| Valsartan |
Valsartan Tablets Valsartan and Hydrochlorothiazide Tablets Amlodipine and Valsartan Tablets |
| Losartan Potassium |
Losartan Potassium Tablets Losartan Potassium and Hydrochlorothiazide Tablets |
| Irbesartan |
Irbesartan Tablets Irbesartan and Hydrochlorothiazide Tablets |
Should you have any questions or comments, please contact Donald Min, Ph.D., Senior Scientific Liaison, Chemical Medicines at 301-230-7457 or DDM@usp.org.
CN-21-044-00