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Recall Observatory FDA recall evidence

Drug product

Oxytocin 30 unit in LR 500 mL 0.06 units/mL IV,Pharm D Solutions, Houston, Texas --- NDC 69699-1203-50

D-0169-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
264 vials
Official record key
drug-enforcement:D-0169-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 03152018:12 Discard by: 6/13/2018; 04182018:08 Discard by: 7/17/2018; 04302018:94 Discard by: 7/29/2018; 03292018:44 Discard by: 6/26/2018; 05212018:95 Discard by: 8/19/2018; 06142018:46 Discard by: 9/12/2018; 05312018:37 Discard by: 8/29/2018; 06282018:80 Discard by: 9/26/2018; 07312018:12 Discard by: 10/29/2018; 07102018:53 Discard by: 10/8/2018; 08222018:18 Discard by: 11/20/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility