FDA recall D-0540-2023

Product

Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).

Reason for recall

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Distribution

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2023-04-07

Report date

2023-05-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Coral Springs, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2023