Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.
Why it was recalled
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
- Firm
- Physicians Total Care, Inc.
- Notification channel
- FAX
- Type
- Voluntary: Firm initiated
- Address
- 12515 E 55th St Ste 100, Tulsa, Oklahoma 74146-6234
Distribution
- Quantity
- 60 bottles
- Distribution pattern
- GA, PA
Timeline
- Recall initiated
- 2011-03-18
- FDA classified
- 2012-06-22
- Posted by FDA
- 2012-07-04
- Terminated
- 2013-02-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1391-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.