FDA-Drug2023-05-03Class II
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).
Methapharm Inc
Hazard
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Sold states
Nationwide in the USA
Affected count
5377 cartons
Manufactured in
11772 W Sample Rd Ste 101, N/A, Coral Springs, FL, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0540-2023Don't want to check this manually?
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