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FDAFDA · Food and drugs·Recall number D-1282-2019

Losartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated

Published May 29, 2019 · Recall initiated: May 1, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Golden State Medical Supply Inc.
Distributor
IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Lot
GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020
Risk classification
Class II
Area (FDA)
drug
Country
United States

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