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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1574-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
78 ml total
Official record key
drug-enforcement:D-1574-2015

Official wording

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information: All lots distributed between November 2014 and May 2015; 04212015@36, 7/20/2015; 03202015@56, 6/18/2015; 03182015@10, 6/16/2015

Distribution pattern: Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP violations
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility