FDA recall D-0576-2023

RemedyRepack Inc. · Class II · drug

Product

LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyRepack Inc., Indiana PA 15701, Source NDC # 17478-0040-01, Remedy NDC 70518-2268-00

Reason for recall

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Distribution

Product was distrituded to three direct account in PA.

Key facts

Status
Terminated
Initiation date
2023-05-01
Report date
2023-05-24
Termination date
2023-06-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0576-2023