FDAFDA · Food and drugs·Recall number D-0893-2022
Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540
Published June 1, 2022 · Recall initiated: May 11, 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
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Direct Rx
- Distributor
- FL
- Lot
- Lot: 25OC2116 Exp. 5/31/23
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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