Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
Reported: May 8, 2019 Initiated: April 22, 2019 #D-1270-2019
Product Description
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
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
- RemedyRepack Inc.
- Units Affected
- 44 HDPE bottles of 90 = 3,960 tablets
- Distribution
- Product was distributed to Florida.
- Location
- Indiana, PA
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.. Recalled by RemedyRepack Inc.. Units affected: 44 HDPE bottles of 90 = 3,960 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-1270-2019.
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