Valsartan and Hydrochlorothiazide Tablets recall: Impurity Out of Spec
Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals…
Why was Valsartan and Hydrochlorothiazide Tablets recalled?
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
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 # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019
- Product
- Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 5,660 bottles
- Distribution
- Product was distributed throughout the United States.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)