Losartan Potassium/ Hydrochlorothiazide Tablets recall: Impurity Out of Spec
Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge…
Why was Losartan Potassium/ Hydrochlorothiazide Tablets 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 4P04D007
- Product
- Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 8,688 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- October 9, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)