Recalls / Class II
Class IID-1581-2019
Product
Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA, NDC 68180-519-02
- 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
- Lot #:H801815, Exp. March 2021
Why it was recalled
Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg observed in 500 s count product bottle.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 11,832 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2019-07-19
- FDA classified
- 2019-07-31
- Posted by FDA
- 2019-07-31
- Terminated
- 2020-09-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1581-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.