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Recall Observatory FDA recall evidence

Drug product

Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1569-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
1588 ml total
Official record key
drug-enforcement:D-1569-2015

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; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015; 05012015@52, 7/30/2015; 04242015@64, 7/1/2015; 04302015@3, 7/29/2015; 04302015@40, 7/29/2015; 04302015@43, 7/29/2015; 04292015@99, 7/28/2015; 05062015@19, 8/4/2015; 05122015@14, 7/11/2015

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