Losartan Potassium Tablets USP 50 mg 50 tablets recall: Impurity Out of Spec
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Why was Losartan Potassium Tablets USP 50 mg 50 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 0.96 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: 20121 Exp. 6/30/2019
- Product
- Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
- Recalling firm
- AVKARE Inc.
- Quantity
- 1438 cartons (71,900 tablets)
- Distribution
- Nationwide
- Recall date
- May 8, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)