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.
Reported: July 17, 2019 Initiated: January 10, 2019 #D-1466-2019
Product Description
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.
Reason for Recall
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
Details
- Recalling Firm
- MAJOR PHARMACEUTICALS
- Units Affected
- 3,102 Cartons (310,200 tablets)
- Distribution
- Nationwide.
- Location
- Livonia, MI
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by MAJOR PHARMACEUTICALS. Units affected: 3,102 Cartons (310,200 tablets).
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 17, 2019. Severity: Moderate. Recall number: D-1466-2019.
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