FDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations
Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall involving Current Good Manufacturing Practice deviations and above-limit azido impurities in a prescription medication. Although no illnesses or injuries are reported, the manufacturing quality issue with impurities exceeding acceptable limits in a blood pressure medication represents a risk-of-harm product warranting High severity.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets, 100 mg/25 mg strength, in 30, 90, and 1000-count bottles. The recall affects lot BLM2114A with an expiration date of July 2023 that was distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing testing. Testing revealed that azido impurity levels in the affected lot exceeded acceptable quality limits.
Consumers who have this product should contact their pharmacy or healthcare provider. Do not stop taking blood pressure medication without first consulting a healthcare provider, as abrupt discontinuation can be medically unsafe.
The recalled product
- Product
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
- Brand
- LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug
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 (2)
- Lot # BLM2114A
- exp. date 07/2023
UPCs (7)
- 0333342051448
- 0333342050106
- 0333342052100
- 0333342051103
- 0333342052445
- 0333342051073
- 0333342052070
Distribution
Distributed nationwide across the United States.
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