Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made Supply Disruption — Mylan Laboratories Limited, (
Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made Supply Disruption — Mylan Laboratories Limited, ( is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made; Manufacturer: Mylan
| Drug name | Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made |
|---|---|
| Manufacturer | Mylan Laboratories Limited, (Nashik FDF) |
| Recall/Disruption reason | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in |
| Risk classification | Moderate Risk — Temporary Health Consequence |
| Status | Ongoing |
| Record type | Enforcement/Recall |
| Recall number | D-0321-2019 |
| Initiation date | 20181204 |
| Quantity affected | 76,516 HDPE bottles |
| Dosage form | Drugs |
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