Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
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.
Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets…
Reason Presence of foreign substance: plastic-like substance.
Reason Failed Impurities/Degradation Specifications
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