Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods…
Reason Presence of foreign substance: plastic-like substance.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: LOSARTAN POTASSIUM, Tablet, 50 mg may have potentially been mislabeled as the following drug: MIDODRINE HCL, Tablet, 2.5 mg, NDC 00185004001, Pedigree: W003265, EXP: 6/17/2014.
LOSARTAN POTASSIUM, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093736598.
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 Presence of foreign substance: plastic-like substance.
Reason Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
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