Drug Recall Enforcement Report Class I voluntary initiated by Novartis Pharmaceuticals Corp., originally initiated on 05-11-2019 for the product 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. The product was recalled due to cross contamination with other products: product is being recalled due to possible cross-contamination with peanut flour.. The product was distributed nationwide and the recall is currently terminated.
| Field Name |
Field Value |
| Event ID |
82820 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes). |
| Recall Number |
D-1309-2019 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes). |
| Recall Classification |
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified". |
| Distribution Pattern |
Nationwide with in the United States What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included. |
| 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. |
| Reason For Recall |
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. What is the Reason for Recall?
Information describing how the product is defective. |
| Product Quantity |
792 cartons Product Quantity
The amount of product subject to recall. |
| Voluntary Mandated |
Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order. |
| Report Date |
05-29-2019 |
| Recall Initiation Date |
05-11-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall. |
| Termination Date |
11-28-2023 What is the Date Terminated?
The date that FDA terminated the recall. |
| Initial Firm Notification |
Press Release Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall. |
| Product Type |
Drugs |
| Recalling Firm |
Novartis Pharmaceuticals Corp. |
| Code Info |
Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020. Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling. |
| Recalled NDC Packages |
0078-0684-15; 0078-0685-15; 0078-0686-15; 0078-0686-55; 0078-0687-15; 0078-0972-19; 0078-0972-23; 0078-0972-61; 0078-0697-19; 0078-0697-23; 0078-0697-61 |
| Status |
Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. |
Recalled Products