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Recall Observatory FDA recall evidence

Drug product

HCG Lyopholized 1200 IU Injectable, Pharm D Solutions, Houston, Texas ---- NDC 69699-1743-12

D-0160-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
881 vials
Official record key
drug-enforcement:D-0160-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04092018:58 Discard by: 10/6/2018; 06072018:03 Discard by: 12/4/2018; 05292018:86 Discard by: 11/25/2018; 07192018:64 Discard by: 1/15/2019; 08302018:30 Discard by: 2/26/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility