Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Foreign Substance; some bottles may contain debris that was swept up during cleaning
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
LOSARTAN POTASSIUM Tablets, USP, 50 mg, 30 count bottles, Rx only, Manufactured by Arrow Pharm (Malta) Ltd., Bizebbugia, Malta, Packaged by GSMS, Inc. Camarillo, CA --- NDC 60429-317-30
Compare with the code on your package — it is the most precise check available.
Drug: Losartan Category: Blood Pressure Medication
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Presence of foreign substance: plastic-like substance.
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
CGMP deviations: tablets with black specks.
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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