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Recall Observatory FDA recall evidence

Drug product

PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA

D-0176-2016

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- 5ml vial, 1- 10 ml vial
Official record key
drug-enforcement:D-0176-2016

Official wording

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

Code information: 5 ml --- 07062015@1, exp 1/2/2016; ---- 10 ml --- 07272015@3, exp 1/23/2016

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