FDAFDA · Food and drugs·Recall number D-0124-2020
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Published October 9, 2019 · Recall initiated: September 19, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Torrent Pharma Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Lot 4P04D007
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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