Recalls / Class II
Class IID-0188-2024
Product
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
- Brand name
- Lisinopril And Hydrochlorothiazide
- Generic name
- Lisinopril And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Lisinopril
- Route
- Oral
- NDCs
- 68180-518, 68180-519, 68180-520
- FDA application
- ANDA077912
- Affected lot / code info
- Batch Q101699, Q101981
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm
- Firm
- CARDINAL HEALTHCARE
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7200 Cardinal Pl W, Dublin, Ohio 43017-1094
Distribution
- Quantity
- 2 units
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2023-12-26
- Posted by FDA
- 2024-01-03
- Terminated
- 2024-09-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0188-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.