FDA recall D-1030-2020

RemedyRepack Inc. · Class II · drug

Product

Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0519-02 (Original NDC of 500 count bottle); 70518-0382-03 (Repackaged NDC for blister cards).

Reason for recall

Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.

Distribution

PA

Key facts

Status
Terminated
Initiation date
2019-08-05
Report date
2020-03-25
Termination date
2023-06-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1030-2020