FDA Drug recall D-0311-2019
Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,…
- FDA Drug
- Class II
- ongoing
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,… by Mylan Pharmaceuticals, citing CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0311-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-20 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Pharmaceuticals |
| Distribution | US |
Product
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.
Reason
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Identifiers
| ndc | 0378-1721-93 |
|---|---|
| ndc | 0378-1722-93 |
| ndc | 0378-1723-93 |
| ndc | 0378-1724-93 |
| code_info | Lot # 3066051, exp. date 3/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0311-2019%22
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