Pantoprazole sodium for Injection 40 mg*/vial recalled over manufacturing violations

Recall date

April 7, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Methapharm Inc recalls Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Metha…

Recall number

D-0540-2023

FDA classification

Class II

Brand / firm

Methapharm Inc

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).