FDA recall D-804-2013

Fresenius Kabi USA, LLC · Class II · drug

Product

Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

Reason for recall

Subpotent Drug; 15-month stability test station

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2013-06-24
Report date: 2013-07-24
Termination date: 2015-04-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-804-2013