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Recall Observatory FDA recall evidence

Drug product

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

D-1533-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
200 ml total
Official record key
drug-enforcement:D-1533-2015

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; 04092015@59, 6/8/2015; 04162015@28, 6/15/2015; 03272015@2, 5/26/2015; 03302015@34, 5/29/2015; 04062015@71, 6/5/2015; 04162015@54, 6/15/2015; 05012015@36, 6/30/2015; 05112015@5, 7/10/2015

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