Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason Presence of foreign substance: plastic-like substance.
Losartan Potassium Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
What was recalled
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-044-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0832-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Losartan recalls
See all
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk Terminated
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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