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Recall Observatory FDA recall evidence

Drug product

Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

D-1436-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
130 mL total
Official record key
drug-enforcement:D-1436-2015

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; 12052014@40, 6/3/2015; 12182014@71, 6/16/2015; 01022015@12, 7/1/2015; 02112015@56, 8/10/2015; 02132015@47, 8/12/2015; 03062015@26, 9/2/2015; 03312015@23, 9/27/2015; 04162015@2, 10/13/2015; 05012015@26, 10/28/2015; 05072015@15, 11/3/2015

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