Quinapril and Hydrochlorothiazide Tablets Recalled Due to Manufacturing Impurity
Aurobindo Pharma USA Inc. is recalling Quinapril/Hydrochlorothiazide Tablets 20mg/12.5mg due to N-nitroso-quinapril impurity above acceptable limits from manufacturing deviations. Affected lots QE2021005-A and QE2021010-A were 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 for manufacturing impurity above acceptable limits. The hazard is a risk-of-harm product where injury has not yet been reported, meeting the severity rubric Score 3 (High) criteria.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Quinapril/Hydrochlorothiazide Tablets, USP 20mg/12.5mg in 90-tablet bottles due to manufacturing deviations that resulted in detection of N-nitroso-quinapril impurity above the acceptable daily intake limit.
The affected lots are QE2021005-A and QE2021010-A with expiration date 01/2023. Approximately 9,504 bottles were distributed nationwide. The product is identified by NDC 65862-162-90 and was manufactured in India.
Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance before making any changes to their treatment. Do not discontinue the medication without medical advice. Return any unused medication from the affected lots to a pharmacy for proper disposal.
The recalled product
- Product
- QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE (QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE)
- Brand
- QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Affected units
- 9,504
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)
- Lots QE2021005-A and QE2021010-A
- exp 01/2023
UPCs (1)
- 0365862161901
Distribution
Distributed nationwide across the United States.
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