Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Reported: December 19, 2018 Initiated: November 20, 2018 #D-0318-2019
Product Description
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.
Reason for Recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 48,302 bottles
- Distribution
- Product was distributed throughout the United States.
- Location
- Morgantown, WV
Frequently Asked Questions
What product was recalled? ▼
Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1724-93.. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 48,302 bottles.
Why was this product recalled? ▼
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 19, 2018. Severity: Moderate. Recall number: D-0318-2019.
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