FDAFDA · Food and drugs·Recall number D-1164-2022
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Published July 6, 2022 · Recall initiated: June 10, 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 # BLM2114A, exp. date 07/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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