Metoprolol Succinate
FDA Recall NDC 0378-4597
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Metoprolol Succinate (NDC 0378-4597). A significant event, classified as Class II, was initiated on Jul 03, 2014 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol"
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
Class II Terminated
Presence of Foreign Tablets/Capsules: A pharmacist reported a rogue tablet of different size and markings in bottle of Metoprolol
Jul 03, 2014
Oct 15, 2014
15,966 bottles
Recall Profile & Regulatory Data
Event ID
68783
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 20, 2016
Product Description
Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
Batch or Lot Expiration Information
Lot# Lot 3023805 Exp. 11/15
Affected Packages Involved in this Recall
0378-4595-77Product
0378-4595-10Product
0378-4596-77Product
0378-4596-10Product
0378-4597-77Product
0378-4597-10Product
0378-4598-77Product
0378-4598-05Product
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.
