Mirtazapine Tablet, Film Coated
FDA Recall NDC 0378-3545
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Mirtazapine (NDC 0378-3545). A significant event, classified as Class II, was initiated on Jan 19, 2017 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
January 2017 Class II Recall: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle
Jan 19, 2017
Mar 15, 2017
37,445 bottles
Recall Profile & Regulatory Data
Event ID
76357
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 12, 2017
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
0378-3515-70Product
0378-3515-93Product
0378-3515-01Product
0378-3515-10Product
0378-3530-70Product
0378-3530-93Product
0378-3530-01Product
0378-3530-05Product
0378-3545-70Product
0378-3545-93Product
0378-3545-01Product
0378-3545-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
