Recalls / Class II
Class IID-1413-2020
Product
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
- Brand name
- Lisinopril
- Generic name
- Lisinopril
- Active ingredient
- Lisinopril
- Route
- Oral
- NDCs
- 68001-332, 68001-337, 68001-333, 68001-486, 68001-334, 68001-335, 68001-336
- FDA application
- ANDA077321
- Affected lot / code info
- Lot # Q000232, exp. date 01/2022
Why it was recalled
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- BluePoint Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 11,688 bottles
- Distribution pattern
- Product was distributed to OH and may have been further distributed throughout the United States.
Timeline
- Recall initiated
- 2020-07-17
- FDA classified
- 2020-07-28
- Posted by FDA
- 2020-08-05
- Terminated
- 2021-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1413-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.