FDAFDA · Food and drugs·Recall number D-1081-2019
Losartan 50mg Tablet, 30 count each blister card.
Published April 17, 2019 · Recall initiated: March 14, 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; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to one sole customer, Miami, FL.
- Lot
- 70518-0588-01, Lot #: J0328416-101518, Exp. Date: 10/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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