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Recall Observatory FDA recall evidence

Drug product

Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20

D-0137-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
7150 milliliters
Official record key
drug-enforcement:D-0137-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: 04112018:83 Discard by: 10/8/2018; 03202018:48 Discard by: 9/16/2018; 04302018:91 Discard by: 10/27/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility