FDAFDA · Food and drugs·Recall number D-1102-2020
LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
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
- 1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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