Losartan Potassium Tablets USP 50 mg recall: Impurity Out of Spec
Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx…
Why was Losartan Potassium Tablets USP 50 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
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?
a) CL018008A, exp Mar 2020; b) CL018008B, exp Mar 2020; c) CL018009A, exp Mar 2020
- Product
- Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx…
- Recalling firm
- Avet Pharmaceuticals, Inc.
- Quantity
- a) 2,904; b) 14,316; c) 1,368 bottles
- Distribution
- Nationwide
- Recall date
- April 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)