FDAFDA · Food and drugs·Recall number D-1103-2020
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-09
Published April 15, 2020 · Recall initiated: March 26, 2020
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Avet Pharmaceuticals, Inc.
- Distributor
- Nationwide
- Lot
- a) CL018008A, exp Mar 2020; b) CL018008B, exp Mar 2020; c) CL018009A, exp Mar 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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