FDAFDA · Food and drugs·Recall number D-1466-2019
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Published July 17, 2019 · Recall initiated: January 10, 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: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Recall details
- Manufacturer
- MAJOR PHARMACEUTICALS
- Distributor
- Nationwide.
- Lot
- Major Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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