Losartan Potassium Tablets recall: Impurity Out of Spec
LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by…
Why was Losartan Potassium 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.
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] Lots 4DU3E014, 4DU3E015, exp 1/31/2021; Lot 4DU3E065, exp 7/31/2021; [1000-count bottle] Lot 4DU3D018, exp 11/30/2020; Lots 4DU3E062, 4DU3E063, exp 6/30/2021
- Product
- LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b) 1000-count (NDC: 13668-115-10), per bottle, Rx only, Manufactured by…
- Recalling firm
- Torrent Pharma Inc.
- Quantity
- 121,668 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- April 17, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)