FDA Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Temperature Storage Deviations
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets (10mg/12.5mg) manufactured by Lupin Limited because products were exposed to temperatures outside the labeled storage conditions. Affected batches are Q101699 and Q101981 distributed nationwide.
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 drug recall involving a CGMP deviation where product stability may be compromised due to improper storage temperatures. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported, consistent with a High (3) severity classification.
Plain-English summary
Cardinal Healthcare is recalling Lisinopril and Hydrochlorothiazide Tablets USP (10mg/12.5mg) manufactured by Lupin Limited. The product batches Q101699 and Q101981 were exposed to temperatures outside of the labeled storage conditions, which is a current good manufacturing practice (CGMP) deviation.
The recalled product is a prescription combination medication used to treat high blood pressure. The affected NDC is 68180-518-01 and the product was distributed nationwide.
Temperature exposure outside labeled storage conditions can potentially affect medication stability and efficacy. Patients who have received this medication should contact their healthcare provider or pharmacist if they have any concerns or questions about their supply.
The recalled product
- Product
- LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
- Brand
- LISINOPRIL AND HYDROCHLOROTHIAZIDE
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug
- Hazard
- temperature-excursion
- stability-risk
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)
- Batch Q101699
- Q101981
UPCs (3)
- 0368180519010
- 0368180518013
- 0368180520016
Distribution
Distributed nationwide across the United States.
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