FDAFDA · Food and drugs·Recall number D-1455-2019
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Published July 17, 2019 · Recall initiated: June 6, 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: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide by 4 major distributors.
- Lot
- Arrow Malta (Teva) Bulk Product Lot # 1169752A, exp. date 01/2020, 1000 tablets/bottle 1169753A, exp. date 01/2020, 90 tablets/bottle Golden State Medical Finished Product Lot # GS017387, exp. date 01/2020 GS017651, exp. date 01/2020 GS017479, exp. date 01/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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