FDA recall D-1117-2019

Product

Losartan Potassium / Hydrochlorothiazide Tablets, USP 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10) per bottle , Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India. For: Torrent Pharma, Inc, 150 Allen Road, Suite 102, Basking Ridge, NJ

Reason for recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.

Distribution

Nationwide USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2019-02-28

Report date

2019-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Basking Ridge, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1117-2019