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Recall Observatory FDA recall evidence

Drug product

PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

D-0171-2016

October 07, 2015

Class II

Product summary

Firm
Pacific Healthcare, Inc dba B&B Pharmacy
Event
Event 72361
Status
Terminated
Classification
Class II
Quantity
3 vials
Official record key
drug-enforcement:D-0171-2016

Official wording

Reason: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Code information: 05072015@7, exp 11/3/2015; 05182015@3, 11/14/2015; 07152015@, 1/11/2016

Distribution pattern: CA and NJ

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