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Recall Observatory FDA recall evidence

Drug product

Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

D-1679-2015

June 02, 2015

Class II

Product summary

Firm
The Compounding Pharmacy of America
Event
Event 71371
Status
Terminated
Classification
Class II
Quantity
67 ml
Official record key
drug-enforcement:D-1679-2015

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@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 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