FDAFDA · Food and drugs·Recall number D-1266-2019
Losartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Published May 8, 2019 · Recall initiated: April 18, 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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Torrent Pharma Inc.
- Distributor
- Nationwide USA and Puerto Rico
- Lot
- Count, lots, expiry: [90-count bottle] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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