Cabergoline Tablet
FDA Recall NDC 0093-5420
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 Cabergoline (NDC 0093-5420). A significant event, classified as Class III, was initiated on Apr 24, 2012 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life"
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
Impurities/Degradation Products: This lot of product will not meet the impurity specification over shelf life
Apr 24, 2012
Jan 23, 2013
13,232 bottles
Recall Profile & Regulatory Data
Event ID
61725
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 18, 2013
Product Description
CABERGOLINE Tablets, 0.5 mg, RX only, 8 count bottles, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 NDC 0093-5420-88
Batch or Lot Expiration Information
Lot# Lot number 6A007046V, exp 07/12
Affected Packages Involved in this Recall
0093-5420-88Product
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.
