Methylprednisolone Tablet
FDA Recall NDC 0603-4593
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 Methylprednisolone (NDC 0603-4593). A significant event, classified as Class III, was initiated on Sep 11, 2014 by Endo Usa, Inc.. The reported reason for this action was: "Subpotent; 6 month stability time point"
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 III Terminated
Subpotent; 6 month stability time point
Sep 11, 2014
Oct 01, 2014
159,913 tablets
Recall Profile & Regulatory Data
Event ID
69233
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Qualitest Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 27, 2016
Product Description
MethylPREDNISolone TABLETS, USP 4 mg, a) 100 count bottles (NDC 0603-4593-21) and b) 21 count blister pack (NDC 0603-4593-15), Rx only, Mfg for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
Batch or Lot Expiration Information
Lot# 100 count: T147F13A, Exp. 05/2015; 21 count: S003M14, Exp. 05/2015
Affected Packages Involved in this Recall
0603-4593-21Product
0603-4593-15Product
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.
