FDA recall D-1538-2022

Product

Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00

Reason for recall

Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.

Distribution

Distributed to two direct accounts in PA and AK.

Key facts

Status

Terminated

Initiation date

2022-09-15

Report date

2022-09-21

Termination date

2022-11-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1538-2022