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, which indicates a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences. The presence of a nitrosamine impurity (NMBA) in a prescription drug is a significant safety concern that aligns with the 'Severe' severity criteria for drug recalls involving potential health risks.
Plain-English summary
Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg, 90-count bottles. The recall involves 142,626 bottles containing a total of 12,836,340 tablets. The product was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity identified as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products. The affected lot codes are BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, BLK725A, BLK726A, BLK804A, BLK806A, BLK825A, and BLK826A, with expiration dates ranging from September 2019 to October 2021.
Consumers and healthcare providers should check their inventory for the specific NDC numbers and lot codes listed in the recall notice. If the product is found, it should be returned to the pharmacy or distributor for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if they have been taking the recalled medication.
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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