Losartan Potassium and Hydrochlorothiazide Recall: Impurity Levels Above Acceptable Limits
Direct Rx is recalling Losartan Potassium and Hydrochlorothiazide tablets due to azido impurity levels above acceptable limits resulting from manufacturing deviations. Patients should consult their healthcare provider regarding their medication.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving impurity levels above acceptable limits in a prescription drug due to CGMP deviations. No illnesses or injuries are reported in the source material, making this a theoretical risk rather than proven harm. Per the severity rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3 (High).
Plain-English summary
Direct Rx is recalling 11 bottles of Losartan Potassium and Hydrochlorothiazide (100/12.5 mg, 90 tablets per bottle) due to Current Good Manufacturing Practice (CGMP) deviations. The recalled medication has lot number 25OC2116 with an expiration date of May 31, 2023, and was distributed in Florida.
The recall was initiated because azido impurity levels in the affected bottles were observed to be above acceptable limits. This represents a manufacturing quality issue identified during product oversight.
If you have this medication, do not use it. Consult your healthcare provider or pharmacist immediately to discuss your treatment options and obtain appropriate replacement medication.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Direct Rx
- Hazard
- azido-impurity
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 25OC2116 Exp. 5/31/23
Distribution
Distributed in 1 state:
- FL
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Same brand · LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
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- HighBlood Pressure Medication Recalled for Manufacturing Impurity
FDA (Drugs) · 2022-06-01
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FDA (Drugs) · 2022-06-01
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