FDA recall D-1413-2020

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08

Reason for recall

Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg

Distribution

Product was distributed to OH and may have been further distributed throughout the United States.

Key facts

Status
Terminated
Initiation date
2020-07-17
Report date
2020-08-05
Termination date
2021-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1413-2020