Drug & medication recalls High risk

Novartis Pharmaceuticals Corp. recalls Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New J…

Recall date
May 11, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-1309-2019
FDA classification
Class I
Brand / firm
Novartis Pharmaceuticals Corp.
Sold / distributed
Nationwide with in the United States

Why it was recalled

Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.

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