FDAFDA · Food and drugs·Recall number D-1288-2019
Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-09
Published May 29, 2019 · Recall initiated: May 3, 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
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Distributor
- Nationwide
- Lot
- Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp 01/2020 Lot CLO18020A exp 04/2020 Lot CLO18021A exp 04/2020 Lot CLO18022A exp 04/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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