FDAFDA · Food and drugs·Recall number D-1051-2019
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Published March 27, 2019 · Recall initiated: March 6, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc
- Distributor
- California, Georgia, Indiana
- Lot
- Count, lots, expiry: a) 30-count bottle C2218C, exp 9/2020, D1318E, exp 10/2020; b) 90-count bottle C2719J, exp 9/2020, E1818B, exp 10/2020.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.