Promacta Tablet, Film Coated
FDA Recall NDC 0078-0686
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 Promacta (NDC 0078-0686). A significant event, classified as Class I, was initiated on May 11, 2019 by Novartis Pharmaceuticals Corporation. The reported reason for this action was: "Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour."
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 I Terminated
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
May 11, 2019
May 29, 2019
792 cartons
Recall Profile & Regulatory Data
Event ID
82820
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Novartis Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide with in the United States
Termination Date
Nov 28, 2023
Product Description
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.
Batch or Lot Expiration Information
Lot# : 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Affected Packages Involved in this Recall
0078-0684-15Product
0078-0685-15Product
0078-0686-15Product
0078-0686-55Product
0078-0687-15Product
0078-0972-19Product
0078-0972-23Product
0078-0972-61Product
0078-0697-19Product
0078-0697-23Product
0078-0697-61Product
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.
