FDA recall D-1148-2014

Fresenius Kabi USA, LLC · Class II · drug

Product

Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.

Reason for recall

Subpotent; 18 month time point

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-01-22
Report date: 2014-03-12
Termination date: 2016-05-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grand Island, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1148-2014