FDA recall D-0493-2017
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) · Class II · drug
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 for recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Distribution
Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-01-27
- Report date
- 2017-03-15
- Termination date
- 2019-03-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Rockford, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0493-2017