Recalls / Class II
Class IID-0492-2017
Product
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
- Brand name
- Mirtazapine
- Generic name
- Mirtazapine
- Active ingredient
- Mirtazapine
- Route
- Oral
- NDCs
- 0378-3515, 0378-3530, 0378-3545
- FDA application
- ANDA076122
- Affected lot / code info
- a) 3078937 and 3078938 (NDC 0378-3545-93), exp August 2019 b) 3078937 (NDC 0378-3545-01), exp August 2019 c) 3078936 (0378-3545-05), exp August 2019
Why it was recalled
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 37,445 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-01-19
- FDA classified
- 2017-03-08
- Posted by FDA
- 2017-03-15
- Terminated
- 2017-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0492-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.