FDA recall D-1391-2012

Product

Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03

Reason for recall

Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life

Distribution

GA, PA

Key facts

Status

Terminated

Initiation date

2011-03-18

Report date

2012-07-04

Termination date

2013-02-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tulsa, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1391-2012