FDA recall D-0507-2024

Product

Vasopressin Injection, USP, 200 Units per 10 mL (20 Units per mL), 10 mL Multiple-Dose Vial, Rx only, For Intravenous Infusion, American Regent, Inc., Shirley, NY 11967, NDC 0517-1030-01

Reason for recall

Subpotent product in addition to having out-of-specification results for impurities.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-05-13

Report date

2024-05-29

Termination date

2025-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

New Albany, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0507-2024