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Recall Observatory FDA recall evidence

Drug product

Reck Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1459-50

D-0178-2019

September 10, 2018

Class II

Product summary

Firm
Pharm D Solutions, LLC
Event
Event 81002
Status
Terminated
Classification
Class II
Quantity
517 syringes
Official record key
drug-enforcement:D-0178-2019

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot: 03262018:11 Discard by: 4/25/2018; 04102018:38 Discard by: 5/10/2018; 05312018:63 Discard by: 6/30/2018; 05032018:97 Discard by: 6/2/2018; 06082018:24 Discard by: 7/8/2018; 05212018:80 Discard by: 6/20/2018; 07102018:60 Discard by: 8/9/2018; 06202018:44 Discard by: 7/19/2018; 07232018:08 Discard by: 8/22/2018; 07022018:62 Discard by: 8/1/2018; 08292018:95 Discard by: 9/28/2018; 08202018:61 Discard by: 9/19/2018

Distribution pattern: Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility