FDA Drug recall D-0326-2019
Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 2650…
- FDA Drug
- Class II
- ongoing
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 2650… 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-0326-2019 |
| 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 Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.
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 | 0378-5807-93 |
|---|---|
| ndc | 0378-5813-77 |
| ndc | 0378-5814-77 |
| ndc | 0378-5815-77 |
| code_info | Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079…Lot Numbers: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623 |
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-0326-2019%22
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