FDA Drug recall D-0493-2017
Mirtazapine Tablets, USP, 45 mg
- FDA Drug
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of Mirtazapine Tablets, USP, 45 mg by Mylan Institutional D B A Udl Laboratories, citing presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0493-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-27 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
Product
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Reason
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Identifiers
| ndc | 51079-086-01 |
|---|---|
| ndc | 51079-086-20 |
| ndc | 51079-087-01 |
| ndc | 51079-087-20 |
| ndc | 51079-088-01 |
| ndc | 51079-088-20 |
| code_info | Batch #3083289; Exp. Date 12/2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0493-2017%22
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