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] Lot 4DU3E016, exp 01/31/2021; [1000-count bottle] Lot 4DU3C012, exp 7/31/2019; Lots 4DU3C015, 4DU3C016, 4DU3C017, exp 8/31/2019; Lot 4DU3C031, exp 9/30/2019; Lots 4DU3D007, 4DU3D008, exp 1/31/2020; Lot 4DU3E017, exp 1/31/2021; Lot 4DU3E019, exp 2/28/2021
- 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
- 65,184 bottles
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)