Prednisone Intensol Solution, Concentrate
FDA Recall NDC 0054-3721
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Prednisone Intensol (NDC 0054-3721). A significant event, classified as Class II, was initiated on Oct 03, 2016 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Failed Tablet/Capsule Specifications: Discovery of an underweight tablet."
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
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
Oct 03, 2016
Oct 12, 2016
15,109 bottles
Recall Profile & Regulatory Data
Event ID
75260
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceutical
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
Termination Date
Dec 18, 2017
Product Description
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.
Batch or Lot Expiration Information
Lot# 660621A, Exp 01/31/18
Affected Packages Involved in this Recall
0054-4741-25Product
0054-4741-31Product
0054-4742-25Product
0054-4728-25Product
0054-4728-31Product
0054-0017-25Product
0054-0017-29Product
0054-0017-20Product
0054-0018-25Product
0054-0018-29Product
0054-0018-20Product
0054-0019-20Product
0054-0019-25Product
0054-3722-63Product
0054-3722-50Product
0054-3721-44Product
0054-8739-25Product
0054-8740-25Product
0054-8724-25Product
Class III Terminated
Labeling: Missing Label; missing label on blister card
Jun 14, 2013
Aug 21, 2013
14,619 cartons
Recall Profile & Regulatory Data
Event ID
65467
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Boehringer Ingelheim Roxane Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 23, 2014
Product Description
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20
Batch or Lot Expiration Information
Lot# The affected product consists of
Lot# 261739A, expiration date OCT 2014.
Affected Packages Involved in this Recall
0054-4741-25Product
0054-4741-31Product
0054-4742-25Product
0054-4728-25Product
0054-4728-31Product
0054-0017-25Product
0054-0017-29Product
0054-0017-20Product
0054-0018-25Product
0054-0018-29Product
0054-0018-20Product
0054-0019-20Product
0054-0019-25Product
0054-3722-63Product
0054-3722-50Product
0054-3721-44Product
0054-8739-25Product
0054-8740-25Product
0054-8724-25Product
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.
