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Recall Observatory FDA recall evidence

Drug product

Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1726-10

D-0184-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
420 vials
Official record key
drug-enforcement:D-0184-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 04232018:46 Discard by: 10/13/2018; 06252018:30 Discard by: 12/22/2018; 07232018:10 Discard by: 1/19/2019; 08302018:07 Discard by: 2/25/2019

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility