FDA Recall Amlodipine And Valsartan
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The most recent Recall Enforcement Report that covers this product was initiated on December 4th, 2018 and classified as a Class II recall due to gcmp deviations: fda analysis confirmed presence of trace amounts of an impurity, n-nitrosodiethylamine (ndea) found in the api used to manufacture the product. This recall is currently ongoing, and the associated recall number is recall number is D-0320-2019. It pertains to Amlodipine And Valsartan identified by 0378-1724.
| Recall Number | Recall Initiation Date | Report Date | Quantity | Product Description | Recall Reason | Status |
|---|---|---|---|---|---|---|
| D-0320-2019 | 12-04-2018 | 12-19-2018 | 141,995 HDPE bottles | Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Ongoing |
| D-0323-2019 | 12-04-2018 | 12-19-2018 | 84,066 HDPE bottles | Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., NDC 0378-1724-93. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Ongoing |
| D-0321-2019 | 12-04-2018 | 12-19-2018 | 76,516 HDPE bottles | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1722-93. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Ongoing |
| D-0322-2019 | 12-04-2018 | 12-19-2018 | 109,314 HDPE bottles | Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-1723-93. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. | Ongoing |
| D-0312-2019 | 11-20-2018 | 12-19-2018 | 12,336 bottles | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1722-93. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Ongoing |
| D-0311-2019 | 11-20-2018 | 12-19-2018 | 23,478 bottles | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-1721-93. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Ongoing |
| D-0318-2019 | 11-20-2018 | 12-19-2018 | 48,302 bottles | 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. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. | Ongoing |
What is a Recall Enforcement Report?
A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.
When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.
The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.
Understanding Recall Reports
The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.
Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.
If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.
