Home / Recalls / Novartis Pharmaceuticals Corp. / D-1309-2019

D-1309-2019 Class I Terminated

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

FDA drug recall D-1309-2019 was initiated by Novartis Pharmaceuticals Corp. on May 11, 2019 and is designated Class I. Reason for recall: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. The recall status is terminated (terminated Nov 28, 2023). Affected quantity: 792 cartons.

Recall details

Product Type: Drugs
Report Date: May 29, 2019
Initiation Date: May 11, 2019
Termination Date: Nov 28, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 792 cartons

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.

Distribution pattern

Nationwide with in the United States

Code information

Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1309-2019
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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