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Recall Observatory FDA recall evidence

Drug product

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

D-1391-2012

March 18, 2011

Class II

Product summary

Firm
Physicians Total Care, Inc.
Event
Event 62122
Status
Terminated
Classification
Class II
Quantity
60 bottles
Official record key
drug-enforcement:D-1391-2012

Official wording

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

Code information: Lot # 5ASX, Exp 10/31/2011; 5O37; 5QSQ; 5T6J; 5U7Z; 5WIC; 5XDS; 5ZHY; 601J; 63MJ; 64O0, Exp. 02/28/2012.

Distribution pattern: GA, PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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