Recalls / Class II
Class IID-1720-2019
Product
Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bottle, Rx only, Manufactured by for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by: Lupin Limited, Pithampur, 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# H900575, exp. date 01/2022
Why it was recalled
Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on the tablets and brownish/blackish powder observed inside the bottles.
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
- 39,216 bottles
- Distribution pattern
- Product was distributed to wholesalers/distributors and supermarket and drug chains throughout the United States.
Timeline
- Recall initiated
- 2019-07-17
- FDA classified
- 2019-08-09
- Posted by FDA
- 2019-08-21
- Terminated
- 2020-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1720-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.