Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Ma Supply Disruption — Mylan Pharmaceuticals Inc. (M
Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Ma Supply Disruption — Mylan Pharmaceuticals Inc. (M is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Ma; Manufacturer: Mylan
| Drug name | Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Ma |
|---|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
| Recall/Disruption reason | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manuf |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0312-2019 |
| Initiation date | 20181120 |
| Quantity affected | 12,336 bottles |
| Dosage form | Drugs |
🔍 Search all drug supply records →
$1199/mo
Try DrugSupply →