May 2019 FDA Recall Promacta by Novartis Pharmaceuticals Corp.
D-1309-2019 - Cross Contamination with Other Products
This Class I drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on May 11, 2019 for the product Promacta. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1309-2019
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
05-11-2019
05-29-2019
792 cartons
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide with in the United States
11-28-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of 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.
Batch or Lot Expiration Information
Lot# : 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
