Skip to content
Recall Observatory FDA recall evidence

Drug product

PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflower, CA

D-0172-2016

October 07, 2015

Class II

Product summary

Firm
Pacific Healthcare, Inc dba B&B Pharmacy
Event
Event 72361
Status
Terminated
Classification
Class II
Quantity
1 vial
Official record key
drug-enforcement:D-0172-2016

Official wording

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

Code information: 06012015@7, exp 11/28/2015

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