Drug product
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
D-0492-2017
Product summary
- Event
- Event 76357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,445 bottles
- Official record key
drug-enforcement:D-0492-2017
Official wording
Reason: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets