Losartan Potassium Tablets recall: Impurity Out of Spec
LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721…
Why was Losartan Potassium Tablets recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 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?
Count, lots, expiry: [90-count bottle] Lot 4O49C013, exp 09/2019
- Product
- LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 43,416 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- February 27, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)