FDAFDA · Food and drugs·Recall number D-0891-2022
Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5, Pkg Size: 90, NDC: 68788-7758-09.
Published June 1, 2022 · Recall initiated: May 3, 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 · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- Within the U.S in FL and CA.
- Lot
- Lot: K1721D, EXP: 4/30/2023, NDC: 68788-7758-09; Lot: K1021E, EXP: 7/31/2023, NDC: 68788-7758-09.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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