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Recall Observatory FDA recall evidence

Drug product

Human Chorionic Gonadotropin 3000 IU, Rx only, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054 1-844-263-6843 --- NDC: 69699-1738-10

D-0343-2019

November 19, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81629
Status
Terminated
Classification
Class II
Quantity
85 vials
Official record key
drug-enforcement:D-0343-2019

Official wording

Reason: Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Code information: Lot: 10292018:21 Exp. 3/31/2019

Distribution pattern: WA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility