Status
Terminated
Drug Enforcement D-1391-2012
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
Classification
Class II
Report Date
July 4, 2012
Termination Date
February 22, 2013
Product Information
- 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
- Product quantity
- 60 bottles
- 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
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- GA, PA
Location & Firm
- Recalling firm
- Physicians Total Care, Inc.
- Address
-
12515 E 55th St Ste 100
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1391-2012
- Event ID
- 62122
- Recall initiation date
- March 18, 2011
- Center classification date
- June 22, 2012
- Code info
- Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
- More code info
- —