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Recall Observatory FDA recall evidence

Drug product

HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

D-1511-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
61 ml total
Official record key
drug-enforcement:D-1511-2015

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; 03242015@5, 5/23/2015; 05042015@78, 7/3/2015; 03262015@2, 5/25/2015; 04062015@52, 6/5/2015; 04242015@58, 6/23/2015; 05072015@17, 7/6/2015; 05082015@19, 7/7/2015

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