Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Reported: May 8, 2019 Initiated: April 24, 2019 #D-1250-2019
Product Description
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
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 of 0.96 parts per million.
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- 846 cartons (42,300 tablets)
- Distribution
- Nationwide
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478. Recalled by AVKARE Inc.. Units affected: 846 cartons (42,300 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 of 0.96 parts per million.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 8, 2019. Severity: Moderate. Recall number: D-1250-2019.
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