Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle Supply Disruption — Mylan Laboratories Limited, (N
Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle Supply Disruption — Mylan Laboratories Limited, (N is one of 9,000 drug supply records in the DrugSupply dataset. Key details — Drug name: Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle; Manufacturer: Mylan
| Drug name | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle |
|---|---|
| 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-0329-2019 |
| Initiation date | 20181204 |
| Quantity affected | 50,595 HDPE bottles |
| Dosage form | Drugs |
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