FDAFDA · Food and drugs·Recall number D-0885-2022
Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00
Published June 1, 2022 · Recall initiated: May 4, 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
- Recalled product was distributed to Florida.
- Lot
- Lot # B1377711-100521, exp. date 10/31/2022 B1412137-102621, exp. date 10/31/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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