D-0492-2017 Class II Terminated
FDA drug recall D-0492-2017 was initiated by Mylan Pharmaceuticals Inc. on January 19, 2017 and is designated Class II. Reason for recall: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle The recall status is terminated (terminated July 12, 2017). Affected quantity: 37,445 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- March 15, 2017
- Initiation Date
- January 19, 2017
- Termination Date
- July 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,445 bottles
Product Description
Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV
Reason for Recall
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Distribution Pattern
Nationwide
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