Phenobarbital Tablet
FDA Recall NDC 0143-1500
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 Phenobarbital (NDC 0143-1500). 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 Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 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 II Terminated
Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point
Oct 03, 2016
Nov 30, 2016
N/A
Recall Profile & Regulatory Data
Event ID
75261
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 26, 2017
Product Description
Phenobarbital Tablets, USP 60mg 100=count bottles, Rx Only, Mfd. by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 0143-1455-01
Batch or Lot Expiration Information
Lot# : 71294A, Exp. 5/2017
Affected Packages Involved in this Recall
0143-1495-05Product
0143-1495-01Product
0143-1500-05Product
0143-1500-01Product
0143-1455-05Product
0143-1455-01Product
0143-1458-05Product
0143-1458-01Product
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.
