Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
Reported: October 9, 2019 Initiated: September 19, 2019 #D-0124-2020
Product Description
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90
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 9.82 parts per million.
Details
- Recalling Firm
- Torrent Pharma Inc.
- Units Affected
- 8,688 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Basking Ridge, NJ
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90. Recalled by Torrent Pharma Inc.. Units affected: 8,688 bottles.
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 9.82 parts per million.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2019. Severity: Moderate. Recall number: D-0124-2020.
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