Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicia...
FDA Recall #D-1391-2012 — Class II — March 18, 2011
Product Description
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
Recalling Firm
Physicians Total Care, Inc. — Tulsa, OK
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
60 bottles
Distribution
GA, PA
Code Information
Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated