FDAFDA · Food and drugs·Recall number D-1459-2019
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
Published July 17, 2019 · Recall initiated: June 20, 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: 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 · Letter
Recall details
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Distributor
- Nationwide
- UPC
- 0333342051448
- Lot
- BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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