Losartan Potassium and Hydrochlorothiazide Tablets recall: Impurity Out of Spec
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc.…
Why was Losartan Potassium and Hydrochlorothiazide Tablets recalled?
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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: 19454 Exp. 04/30/2019
- Product
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc.…
- Recalling firm
- AVKARE Inc.
- Quantity
- N/A
- Distribution
- Nationwide.
- Recall date
- March 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)