FDAFDA · Food and drugs·Recall number D-1101-2020
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
Published April 15, 2020 · Recall initiated: March 25, 2020
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
- Bulk product was distributed to one re-packager in California.
- Lot
- Lots 1195625A, 1195624A, 1195623A, exp. date 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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