Losartan Potassium 100 mg recall: Impurity Out of Spec
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Why was Losartan Potassium 100 mg 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 per manufacturer
What should I do if I have this product?
Review the official FDA enforcement record for current 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: 27AU1801 Exp. 02/28/2021
- Product
- Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
- Recalling firm
- Direct Rx
- Quantity
- 33 bottles
- Distribution
- GA
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)