FDA Drug recall D-0332-2019
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05),…
- FDA Drug
- Class II
- ongoing
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05),… by Mylan Laboratories Nashik Fdf, citing GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0332-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-12-04 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mylan Laboratories Nashik Fdf |
| Distribution | US |
Product
Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles (NDC 0378-6325-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reason
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Identifiers
| ndc | 0378-6321-77 |
|---|---|
| ndc | 0378-6321-05 |
| ndc | 0378-6322-77 |
| ndc | 0378-6322-05 |
| ndc | 0378-6323-77 |
| ndc | 0378-6323-05 |
| ndc | 0378-6324-77 |
| ndc | 0378-6324-05 |
| ndc | 0378-6325-77 |
| ndc | 0378-6325-05 |
| code_info | Lot numbers: 3084860 3084861 3084862 3093804 3084862 3084863 |
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-0332-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.