Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active ingredient.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the detection of the nitrosamine impurity NMBA in a prescription drug constitutes a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg, 90-count bottles. The recall involves 145,162 bottles, containing a total of 13,064,580 tablets, which were distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.
Patients and consumers should check their medication for the specific lot codes listed in the recall notice. If the medication matches the recalled lot codes, patients should stop using the product and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
UPCs (7)
- 0333342051448
- 0333342050106
- 0333342052100
- 0333342051103
- 0333342052445
- 0333342051073
- 0333342052070
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Macleods Pharma Usa Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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