FDAFDA · Food and drugs·Recall number D-0887-2022
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Published June 1, 2022 · Recall initiated: May 2, 2022
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- AZIDO Impurity levels observed to be above acceptable limits.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- RemedyRepack Inc.
- Distributor
- Product was distributed to FL, SC and VA
- Lot
- Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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