FDA recall D-1079-2020

Lupin Pharmaceuticals Inc. · Class II · drug

Product

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, NDC 68180-982-01

Reason for recall

Presence of Foreign Tablet/ Capsule: Product complaint received indicating mix-up of one lisinopril 5mg tablet inside of a 30 mg, 100-count bottle of Lisinopril Tablets.

Distribution

U.S.A. Nationwide

Key facts

Status: Terminated
Initiation date: 2020-04-01
Report date: 2020-04-08
Termination date: 2021-06-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1079-2020