Recalls / Class II
Class IID-0493-2017
Product
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
- Brand name
- Mirtazapine
- Generic name
- Mirtazapine
- Active ingredient
- Mirtazapine
- Route
- Oral
- NDCs
- 51079-086, 51079-087, 51079-088
- FDA application
- ANDA076122
- Affected lot / code info
- Batch #3083289; Exp. Date 12/2018
Why it was recalled
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Manufacturer
- Mylan Institutional Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-27
- FDA classified
- 2017-03-08
- Posted by FDA
- 2017-03-15
- Terminated
- 2019-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0493-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.