D-0492-2017 Class II Terminated
FDA drug recall D-0492-2017 was initiated by Mylan Pharmaceuticals Inc. on Jan 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 Jul 12, 2017). Affected quantity: 37,445 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 15, 2017
- Initiation Date
- Jan 19, 2017
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0492-2017
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026