FDAFDA · Food and drugs·Recall number D-0837-2022
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Published May 11, 2022 · Recall initiated: April 15, 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
- Macleods Pharma Usa Inc
- Distributor
- Product was distributed nationwide.
- UPC
- 0333342051448
- Lot
- Lot # BLL2107B, exp. date 05/2023 BLL2101A, exp. date 01/2025 BLL2102A, exp. date 02/2025 BLL2103B, exp. date 02/2023 BLL2104A, exp. date 05/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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