Reported Jul 17, 2019 · Terminated
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major…
Major Pharmaceuticals
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MAJOR PHARMACEUTICALS · 17177 N Laurel Park Dr · Livonia, MI · 48152-2693
Is this the product you have?
- Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
- Lot codes and dates
Major Label Unit Does 10 x 10 CartonsMajor Item # 301835
- Lot NumberR-00474
- Expiration date07/2019
- Amount recalled
- 3,102 Cartons (310,200 tablets)
Where it was sold
- Nationwide
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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