Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufac Supply Disruption — Mylan Laboratories Limited, (
Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufac Supply Disruption — Mylan Laboratories Limited, ( is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufac; Manufacturer: Mylan
| Drug name | Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufac |
|---|---|
| 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-0327-2019 |
| Initiation date | 20181204 |
| Quantity affected | 129,754 HDPE bottles |
| Dosage form | Drugs |
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