D-1391-2012 Class II Terminated
FDA drug recall D-1391-2012 was initiated by Physicians Total Care, Inc. on March 18, 2011 and is designated Class II. 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 The recall status is terminated (terminated February 22, 2013). Affected quantity: 60 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 4, 2012
- Initiation Date
- March 18, 2011
- Termination Date
- February 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 bottles
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
Distribution Pattern
GA, PA
Code Information
Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.