FDA recall D-0485-2016

Northwind Pharmaceuticals LLC · Class III · drug

Product

Prednisone 20 mg, Tablet, 10-count bottle, Rx only, Mfg by: HIKMA Pharmaceuticals PO BOX 182400 Amman 11118 Jordan. Dist By: West-Ward Pharmaceuticals Corp., Eatentown, NJ 07724 USA, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46256. NDC 51655-320-53

Reason for recall

Labeling: Not elsewhere classified. NDC number is incorrect on the container.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-11-10
Report date: 2015-12-09
Termination date: 2017-03-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2016