Mirtazapine Tablet, Film Coated
FDA Recall NDC 51079-088
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 51079-088). A significant event, classified as Class II, was initiated on Jan 27, 2017 by Mylan Institutional Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled"
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 tablets commingled
Recall Number
Class II Terminated
Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
Jan 27, 2017
Mar 15, 2017
58 UD100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each)
Recall Profile & Regulatory Data
Event ID
76463
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 15, 2019
Product Description
Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown, WV ---NDC 51079-088-20
Batch or Lot Expiration Information
Batch# 3083289; Exp. Date 12/2018
Affected Packages Involved in this Recall
51079-086-01Product
51079-086-20Product
51079-087-01Product
51079-087-20Product
51079-088-01Product
51079-088-20Product
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.
