Valsartan Tablets recall: Impurity Out of Spec
Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A.…
Why was Valsartan 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 # 3071352, exp. date 7/2019
- Product
- Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A.…
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 12,840 bottles
- Distribution
- Product was distributed throughout the United States.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)